Minimally traumatic trocar apparatus and kit for subcutaneous medication delivery

ABSTRACT

A minimally traumatic trocar apparatus for delivering one or more medication pellets to a subcutaneous insertion site is described. The minimally traumatic trocar apparatus includes a blunt cannula and an obturator. The blunt cannula includes a tubular cannula body having an anterior end with a surface that has a smooth edge. The blunt cannula also includes a medication slot disposed along the tubular cannula body and an inner diameter that is at least 3 millimeters (mm). The obturator includes an anterior rounded tip. The obturator body is inserted within the tubular cannula body so that the obturator extends through the tubular cannula body so that the anterior rounded tip of the obturator extends past the anterior end of the tubular cannula body.

CROSS-REFERENCE

This patent application claims the benefit of provisional patentapplication No. 63/212,509 filed on Jun. 18, 2021 entitled ATRAUMATICTROCAR APPARATUS FOR SUBCUTANEOUS MEDICATION DELIVERY;

this patent application is a continuation-in-part of utility patentapplication Ser. No. 16/997,803 filed on Aug. 19, 2020 entitledATRAUMATIC SUBCUTANEOUS MEDICATION DELIVERY;

this patent application is a continuation-in-part of internationalutility patent application no. PCT/US19/19031 filed on Feb. 21, 2019entitled ATRAUMATIC SUBCUTANEOUS MEDICATION DELIVERY (published as WO2019/165131);

this patent application is a continuation-in-part of utility patentapplication Ser. No. 15/901,837 filed on Feb. 21, 2018 entitledATRAUMATIC TROCAR MEDICATION DELIVERY METHOD (now U.S. Pat. No.10,856,907);

this patent application is a continuation-in-part of utility patentapplication Ser. No. 15/901,821 filed on Feb. 21, 2018 entitledATRAUMATIC TROCAR APPARATUS, SYSTEM AND KIT. All patent applicationsidentified above are hereby incorporated by reference.

FIELD

The present disclosure relates to a minimally traumatic trocarapparatus, system, kit, and method of use. More particularly, thepresent disclosure relates to a trocar apparatus, system and kit thatincludes a cannula that receives an obturator having an anterior roundedtip configured to cause minimal amounts of micro-trauma.

BACKGROUND

Hormone therapies carry significant risks of adverse effects, which canbe exacerbated from inconsistent or traumatic delivery as a result of avariety of hormone therapies. Pills may be forgotten by a patient andrequire relatively frequent pharmacy trips to refill prescriptions.Further, oral delivery can cause gastric distress, destruction of activeingredients (medications), and/or bypass initial metabolism in theliver. Patches may be unsightly, inconvenient, uncomfortable, removedtoo early, and fail to accommodate individuals requiring higher levelsof hormone replacement. Creams may similarly be unsightly andinconvenient, as well as delivering inadequate levels of hormones,requiring repeated application, and allowing for missed applications.Injections require repeated and frequent trips to a doctor's office, andcan be painful. Additionally, pill/oral, patch, cream, and injectiontherapies suffer inconsistent dosage delivery. Dosages of hormonesdelivered by these techniques tend to spike soon after injection,ingestion, or application, then taper quickly below efficaciousmedication levels.

Hormone therapies that utilize subcutaneous implants or “pellets” bypassthe liver, do not affect clotting factors and do not increase the riskof thrombosis. For example, bioidentical testosterone deliveredsubcutaneously by pellet implant is cardiac protective, unlike oral,synthetic methyl-testosterone. Subcutaneous pellets have other practicaladvantages over patches, creams, and injections. Subcutaneous implantsrelease medication consistently for months, freeing patients fromfrequent trips to the doctor as with injections, and eliminatingadherence concerns typical to patient administered medications, such ascreams and oral medications. Alternatively, implants or pellet therapykeep hormone levels consistent through the day and avoidrollercoaster-like effects from orally administered, topicallyadministered, or injected hormones. The release of the drug fromimplanted pellets generally continue for a period of 3 to 6 months, oreven up to 12 months, depending on the size and composition of thepellet.

Subcutaneously implanted hormone pellets may be smaller than a grain ofrice or approximately the size of a marble and are implanted directlyinto the subcutaneous tissue, where they provide a slow continuousrelease of hormone(s) into the bloodstream. Typically, the pellets areimplanted in the lower abdomen or buttocks, because of the generallylarge deposits of fat stored in these areas. The procedure is done in aphysician's office with the use of a local anesthetic and a smallincision for insertion of a trocar.

Trocar medical devices are commonly used to subcutaneously implant thehormone pellets. Trocar medical devices have been known to, and used by,physicians since at least the 19th century and commonly comprise ahollow tubular cannula and a rod-like obturator that fits snugly withinthe cannula. A wide variety of trocars exist that vary according to themedical purpose for which they are intended. Trocars are tailored forspecific tasks, such as laparoscopic surgery or implant delivery.

With reference now to FIGS. 1A-C, there are shown the components of aprior art trocar apparatus for subcutaneous pellet insertion used inBIOTE® hormone replacement therapy. This prior art embodiment, includesan angled cutting edge formed from the angled orifice 102 of the cannula100 and the angled tip 112 of the insertion obturator 110. The insertionobturator 110 is machined to fit within the cannula 100 when assembledinto a trocar, such that the angled tip 112 of the insertion obturator110 is flush with the angled orifice 102 of the cannula 100, forming auniform cutting edge.

As the trocar is inserted into a small surface incision, the angledcutting edge is used to slice through the fatty and connective tissuesimpeding the passage of the trocar. Once inserted to a desired depth orinsertion length, the insertion obturator 110 is removed from thecannula 100 and pellet(s) 104 are loaded into the cannula through aloading slot 106. A blunt delivery obturator 120 is then used in placeof the angled insertion obturator to push the pellet(s) 104 through theangled orifice 102 of the cannula 100.

The delivery obturator 120 delivers the pellet(s) to a subcutaneoussite. The angled orifice 102 facilitates delivery of multiple pellets104 in a clumped orientation. With reference now to FIGS. 1D and 1E, aradial clump of pellets 130 is shown. This radial clump 130 is formed byrotating the cannula during extrusion/delivery of the pellets 104 fromthe angled orifice 102.

The body's primary response to the traumatic cutting insertion of theprior art beveled trocar results in inflamed tissue, lymph fluid, andclotted red blood cells. And the literature from the prior art systemsteach that the inflammatory response triggered by traumatic trocarinsertion of hormone pellets is critical to adequate hormone absorption.

However, prior art traumatic trocar insertion is painful and results inscarring. Additionally, traumatically inserted pellets may lead toinfection or be extruded from the insertion site, which requiresreplacement with an additional traumatic insertion. Furthermore, thebody's inflammatory response to the traumatic insertion causes patientssignificant pain in the days following insertion. Further still, thecutting and spearing motions used to insert angled or cutting edgetrocars cause significant bruising immediately after insertion thatlasts for days or weeks, and further cause scarring that may remain fora year or more. Further yet, this inflammatory response increases thehealing time of the incision, and increases the probability that one ormore pellets may extrude due to external pressures (falling on, sittingon, or bumping the insertion region) or internal pressures (strenuousexercise or muscle contraction).

All of these traumatic trocar insertion concerns are amplifiedparticularly for male testosterone replacement therapy, which requireslarge gauge trocars and high quantities of implanted pellets. The largetrocar gauge and high dosage causes a corresponding amount of pain,scarring, and risk of pellet extrusion.

Therefore, it would be beneficial to provide an apparatus, system, andmethod of subcutaneous pellet delivery that causes minimal amounts ofmicro-trauma to the subcutaneous tissue.

SUMMARY

A minimally traumatic trocar apparatus, kit, and method of use aredescribed. The minimally traumatic trocar apparatus includes a bluntcannula and an obturator. The blunt cannula includes a tubular cannulabody, an anterior end and a medication slot. The anterior end of theblunt cannula includes a smooth edge. The medication slot is disposedalong the tubular cannula body. The blunt cannula has an inner diameterthat is at least 3 millimeters (mm). The obturator includes an anteriorrounded tip and a tubular obturator body. The obturator extends throughthe tubular cannula body so that the anterior rounded tip of theobturator extends past the anterior end of the tubular cannula body.

In some embodiments, the minimally traumatic trocar apparatus includesthe tubular cannula body having an outer diameter of at least 3.5 mm andan inner diameter of at least 3 mm, and the obturator includes an outerdiameter of at least 3 mm.

FIGURES

The presently disclosed subject matter will be more fully understood byreference to the following drawings which are presented forillustrative, not limiting, purposes.

FIG. 1A shows a prior art trocar cannula.

FIG. 1B shows a prior art trocar insertion obturator.

FIG. 1C shows a prior art trocar delivery obturator.

FIG. 1D shows a side view of a prior art radial pellet clump.

FIG. 1E shows a front view of a prior art radial pellet clump.

FIG. 2A shows a perspective view of an illustrative embodiment of thecannula as disclosed herein and in accordance with various embodiments.

FIG. 2B shows a perspective view of an obturator.

FIG. 2C shows a perspective view of the obturator placed within theinterior passage of the cannula.

FIG. 3A shows an end-on view of an illustrative obturator rounded tipwith seven (7) openings.

FIG. 3B shows an end-on view of an illustrative obturator rounded tipwith five (5) openings.

FIG. 3C shows a perspective view of the obturator rounded tip with seven(7) openings proximate to the end of the rounded tip.

FIG. 3D shows an end-on view of an illustrative obturator rounded tipwith two (2) openings.

FIG. 3E shows a perspective view of the obturator rounded tip with two(2) openings proximate to the end of the rounded tip.

FIG. 4A shows a perspective view of the cannula receiving a medicationpellet.

FIG. 4B shows a perspective view of the obturator placed within theinterior passage of the cannula so that the obturator extrudes amedication pellet.

FIG. 5A shows a top view of a disposable obturator.

FIG. 5B shows a perspective view of the disposable obturator.

FIG. 6A shows a top view of a disposable cannula.

FIG. 6B shows a side view of the disposable cannula.

FIG. 6C shows a perspective view of the disposable cannula.

FIG. 7 shows a perspective view of an assembled disposable minimallytraumatic trocar.

FIG. 8 shows a side view of an illustrative hydrodissectionmicrocannula.

FIG. 9A shows a side view of a 90° blunt microcannula with a terminalopening.

FIG. 9B shows a side view of a conical blunt microcannula with aterminal opening.

FIG. 9C shows a side view of a hyperbolically conical microcannula withside opening.

FIG. 9D shows a side view of a pointed conical microcannula with a sideopening.

FIG. 10A shows a side view of an illustrative punch scalpel.

FIG. 10B shows an end-on view of the illustrative punch scalpel.

FIG. 10C shows a bottom view of the illustrative punch scalpel.

FIG. 11A shows an illustrative punch scalpel blade.

FIG. 11B shows a second illustrative punch scalpel blade.

FIG. 12A shows a side view of the illustrative cannula loaded withmedication pellets and the obturator immediately prior to displacementand delivery of the medication pellets.

FIG. 12B shows a side view of the illustrative cannula loaded withmedication pellets and the obturator inserted into the cannula, pushingthe medication pellets into one another and up to an anterior opening ofthe cannula.

FIG. 12C shows a side view of the illustrative cannula loaded withmedication pellets and the obturator inserted into the cannula andpushing the medication pellets into one another so that a firstmedication pellet is displaced.

FIG. 12D shows a side view of the illustrative obturator fully insertedinto the cannula and the pellets fully displaced and extruded asdisclosed herein.

FIG. 13 shows a cut-away view of an illustrative delivery area,assembled minimally traumatic trocar, and side-to-side minimallytraumatic subcutaneous probing techniques.

FIG. 14 shows a cut-away view of an illustrative staggered orientationof subcutaneously inserted pellets.

FIG. 15 shows a cut-away view of an illustrative orientation ofsubcutaneously inserted pellets and assembled minimally traumatictrocar.

FIG. 16 shows a cut-away view of an illustrative orientation of twogroups of subcutaneously inserted pellets.

FIGS. 17A, 17B and 17C show an illustrative minimally traumaticsubcutaneous pellet insertion method.

FIGS. 18A and 18B show a second illustrative minimally traumaticsubcutaneous pellet insertion method.

DESCRIPTION

Persons of ordinary skill in the art will realize that the followingdescription is illustrative and not in any way limiting. Otherembodiments of the claimed subject matter will readily suggestthemselves to such skilled persons having the benefit of thisdisclosure. It shall be appreciated by those of ordinary skill in theart that the systems and methods described herein may vary as toconfiguration and as to details. The following detailed description ofthe illustrative embodiments includes reference to the accompanyingdrawings, which form a part of this application. The drawings show, byway of illustration, specific embodiments in which the invention may bepracticed. It is to be understood that other embodiments may be utilizedand structural changes may be made without departing from the scope ofthe claims.

The apparatus, systems and methods described herein are used to insertan illustrative medication pellet(s) into subcutaneous tissue.Medication pellets may be used for hormone replacement and for otherapplications that would require a relatively slow and sustained releaseof one or more medications. Thus, a single pellet may be compounded tocontain multiple medications, or different medications may be compoundedinto individual pellets and delivered together as separate pellets atone insertion site. Pellets inserted with minimal amounts ofmicro-trauma release medication at consistent and measurable rates forseveral months up to a year or more.

Inventor hypothesizes that deposits of subcutaneous brown adipose tissue(BAT) have superior blood supplies which beneficially improve medicationuptake from subcutaneously inserted medication pellets. Suchsubcutaneous BAT is known to exist in the anterior abdominal wall andalong the vertebral column. As such, the love-handle region, beside thevertebral column (spine), and anterior sides of the abdomen (below andbeside the belly/tummy fat) are possible medication pellet deliverylocations. These locations are preferred for men due the typicallylarger doses of medication required as compared to women, and thecorresponding larger number and size of medication pellets that must beinserted in order to deliver larger doses of medication. Other possibledelivery locations are selected for patient comfort, such as the tensorfascia on the thigh, and the subcutaneous tissue surrounding the gluteusmedius or maximus. The love-handle delivery locations are problematicfor patients of particular professions, such as police officers andconstruction workers because they wear utility belts, which may requireone of the alternate delivery locations to reduce discomfort and thepossibility of extruding delivered medication pellets.

In one therapeutic embodiment, pellets release medication consistentlyfor 6 months before requiring reinsertion of new medication pellets.Upon reaching termination of this 6-month period, the location of thesecond administration of medication pellets may be rotated. For example,the first administration of medication pellets may be placed above apatient's beltline in their right love-handle region, while the secondadministration of medication pellets may be placed above the patient'sbeltline in their left love-handle region. This side-to-side rotationevery 6 months allows for complete healing of the first administrationsite in the patient's right love-handle region prior to any third orre-administration to the patient's right love-handle region, andsimilarly for re-administration to the patient's left love-handleregion.

In general, minimally traumatic implantation requires fewer visits to adoctor's office during a course of treatment compared to injections(lasting for only a matter of days), provides more consistent dosagesthan patches, creams, and pills, and allows for more complete healing ofthe insertion sites between administrations. This makes implants orpellets inserted with minimal micro-trauma more efficacious thanpatches, creams, pills, and traumatically inserted implants or pellets,and more cost effective than injections requiring frequent trips to adoctor's office.

Minimally traumatic subcutaneous medication insertion is also viable fortreating pain. Chronic pain management techniques include subdermalsurgical insertion of a reservoir and/or pump connected to a catheterthat runs directly to the patient's spine to deliver morphine or otheranesthetics. This technique may afford relief to a patient for severalmonths between doctor's visits, however the system costs tens ofthousands of dollars. In contrast, the minimally traumatic trocarapparatus, system, and method disclosed herein is much more affordable,even allowing for single-use disposable embodiments that deliver relieffor several months as well.

As used herein, the term “medication” or “medicinal” includes, but isnot limited to, hormones, hormone therapy, pain medication, addictiontherapy, and other such drugs. More specifically, the term “medication”may be used to refer to drugs such as testosterone, estradiol(estrogen), fentanyl, morphine, various opiates, naltrexone, lidocaineand other such drugs. By way of example and not of limitation,“medication” may refer to hormones, opioids, numbing agents, andcompetitive antagonists in metabolic pathways. For example, “medication”may refer to medicine in pellet form that blocks receptors in the brain,which aid in the treatment of addictive disorders including, but notlimited to, alcohol and narcotics.

Minimally traumatic pellet insertion corresponding to the apparatus,systems, and methods disclosed herein can be used for various regimensthat include hormone therapy, pain management, and addiction treatment.Further, the apparatus, systems, and methods disclosed herein can beemployed in veterinary treatments as well.

With respect to hormone therapy, synthetic, bioidentical, or naturalhormones may be used to supplement endogenous hormones naturallyproduced in the human body. The illustrative apparatus, systems, andmethods disclosed herein pertain to the use of medication implants or“pellets.” The term “pellet” is used generally to describe bothmedication pellets and/or hormone implants. Pellets may be prescribedmedications or custom compounded therapies for symptoms that stem fromhormonal imbalances, to manage hormone levels, to block metabolicpathways involved in the processing of alcohol, opioids, and otheraddictive drugs, and for pain management.

The pellets described herein may be used for hormone therapies such asmenopause and low testosterone. During menopause, individuals experiencesymptoms including hot flashes, sleep disturbances, and night sweats.Sufferers of low testosterone experience chronic fatigue, loss of musclemass, increased body fat (especially in the waist area), decreased bonemass, mood changes, lower mental capacity, depression, brain fog, andirritability. Testosterone helps regulate heart function, and plays apart in sperm production, bone health, energy levels, concentration, andmuscle mass. Most men experience a natural decline in testosterone asthey age, creating a large market for testosterone replacement therapy.

As used herein, the term “hormones” may also refer to synthetichormones, bioidentical hormones and natural hormones. Synthetic hormonesfrequently do not have the same structure as endogenous hormones.Synthetic hormones may mimic the effects of endogenous hormones on manybiological pathways, but they rarely offer the same effectiveness acrossall biological pathways. Bioidenticals are exact structural replicas ofendogenous hormones and are reported to have much lower incidences ofside effects as compared to synthetic hormones. Bioidentical hormonesmay be derived from plants, such as soy or wild yams. Bioidenticalhormones are sometimes defined as molecules identical to a hormoneproduced by the human body. Natural hormones are those produced innature by various organisms, and similar to bioidenticals, are identicalto a hormone produced by the human body.

A minimally traumatic trocar apparatus, system, and method are describedherein. The minimally traumatic trocar apparatus includes a cannula, anobturator, and a hydrodissection microcannula. The cannula includes atubular cannula body having an anterior cannula end with an anteriorcannula opening. The cannula also includes a medication slot disposedalong a portion of the tubular cannula body. As described herein, theobturator is received by the cannula and passes through the interiorpassage of the cannula and exits through the anterior cannula opening.The hydrodissection microcannula includes a tubular microcannula body,an anterior rounded tip, a posterior microcannula opening, and ananterior hydrodissection opening located proximate to the rounded tip.The hydrodissection microcannula is generally of a narrower gauge thanboth the obturator and the cannula. The hydrodissection microcannula isconfigured to deliver hydrodissecting fluid through the anterior openingduring insertion into subcutaneous tissue. This preliminary delivery ofhydrodissecting fluid creates an insertion plane and super-hydrates thetissue surrounding the insertion path. The obturator has a roundedanterior tip and may also include one or more openings near the anteriortip, which are configured to deliver hydrodissecting fluid duringinsertion of the trocar and before insertion of the medication pellets.However, in embodiments employing the hydrodissection microcannula toprepare a super-hydrated insertion path, the obturator may not includeany openings near the anterior tip, and thus not be configured toindependently deliver hydrodissecting fluid. In all embodiments, theobturator is further used to deliver the medication pellets to thesubcutaneous insertion site.

In some embodiments, the obturator may also be used to delivermedication pellets to the subcutaneous insertion site, eliminating theneed for a separate delivery obturator.

The inventor hypothesizes that inserted pellets induce macrophages toaggregate in the injection area through localized angiogenesis.Cytokines can trigger macrophages to transition from innate immunitystatus to an adaptive immunity status that causes such aggregation.Cytokines are small soluble proteins that mediate the body'sinflammatory immune response more generally. Cytokine concentrationstriggering inflammatory response ranges widely from 100's of pg/ml to100's of ng/ml depending upon the various known cytokines. Inventorhypothesizes that serum interleukin-6 is a sensitive, early marker oftissue damage that generally increases concentration at the site oftrauma. As such, the greater the surgical trauma, the greater theresponse of serum interleukin-6 and the greater the peak serumconcentration of interleukin-6, which induces C-reactive proteinsynthesis and inflammation. Localized angiogenesis causes themacrophages to digest the pellet bit by bit from the pellet's outersurface and flush the pellet medication directly into the blood streamover time, resulting in a tissue concentration of the pellet medicationcorresponding to a desired concentration. Thus, a miniscule level oftrauma may improve pellets absorption, while excessive trauma from largebore incising trocars create a much greater inflammatory response thatlubricates an unblocked insertion path and hinders absorption ofinserted pellets. Often the inflammatory response is so strong andhindering that patients require triamcinolone to suppress the responseand enable absorption.

With the atraumatic insertion methods and apparatus disclosed herein, asthe pellet size is increased, the medication release period increases,allowing for medication delivery for a period of days up toapproximately a year or more. Increasing pellet size also reducespatient cost by reducing the frequency of office visits/operations.Further, increased pellet size allows for the insertion of fewer pelletsto achieve the desired amount of medication delivery, i.e. insertion ofa single row of medication pellets instead of requiring two rows ofmedication pellets to achieve the desired amount of medication delivery.Further still, increased pellet size is achieved, indeed only practical,through the minimally traumatic techniques disclosed herein.

The inventor further hypothesizes that a combination of hydrodissectionand administration of tranexamic acid reduce patients' soreness, pain,and/or irritation. The hydrodissection performs several functions:superhydrating and numbing the tissue along the insertion path, as wellas preventing the breakdown of clotted blood for 5-6 hours.Superhydration makes tissue along the insertion path softer and moreeasily shifted during insertion of the minimally traumatic trocarassembly. A later administration of tranexamic acid, such as orally,continues to prevent the breakdown of clotted blood for up to 24 hoursafter the medication pellet insertion and allows those clots tostabilize. Some pain is the result of blood in the insertion space,which irritates pain receptors. A further consequence of reduced amountsof inflammation and blood in the insertion space is improved pelletabsorption, healing, and overall patient experience due to reduced painduring and after pellet implantation.

Referring to FIGS. 2A-C there is shown an illustrative minimallytraumatic trocar apparatus that includes an illustrative cannula and anillustrative obturator. More specifically, FIG. 2A shows an illustrativeembodiment of a cannula 200 having a tubular cannula body 202. Thetubular cannula body 202 includes an anterior cannula opening 204located at an anterior end of the cannula 200. The anterior end of thecannula 200 includes a blunt or rounded cylindrical end, which limitsthe trauma to surrounding tissue during subcutaneous implant procedures.In one embodiment, the cylindrical end of the cannula is blunted bybeveling the end. A bevel blunts the cylindrical end of the cannula inthis structure, because the beveled edge abuts the outer surface of theobturator tubular body and lies flush or very nearly flush against thisouter surface. This blunting may also be achieved with a chamfer, afillet, rounding to create a rounded shape, or any other method ofsmoothing the right angle where the outer surface of the tubular body ofthe cannula meets the cylindrical end of the cannula. In anotherembodiment, the cylindrical end of the cannula is blunted by burnishingthe end. The tubular cannula body 202 further includes a posteriorcannula opening 206 located at a posterior end of the cannula 200. Thetubular cannula body 202 is hollow, providing a passage through thecannula 200 and connecting the anterior cannula opening 204 to theposterior cannula opening 206. Thus, the tubular cannula body 202includes an interior passage disposed between the posterior cannula end206 and the anterior cannula end 204. In various embodiments, theanterior blunt surface surrounds the anterior cannula opening.

In the illustrative embodiment, the cannula 200 further includes a slot208 on a portion of the tubular cannula body 202. The slot 208 isconfigured or sized to receive a medication pellet and thereby allow themedication access to the interior passage of the cannula 200. The slot208 may be located proximate to the anterior cannula end. In analternative embodiment, the cannula 200 may not include a slot on thetubular cannula body 202, instead receiving medication pellets at theposterior end of the cannula.

By way of example and not of limitation, the illustrative medicationpellets described in the embodiments presented herein may include male200 mg testosterone pellets, male 250 mg testosterone pellets, male 300testosterone pellets, and male 303 testosterone pellets. The medicationpellets have lengths ranging from 10 mm to 15 mm and diameters rangingfrom 3 mm to 10 mm. In one embodiment, the medication pellets have alength of 13 mm and a diameter of 4 mm. In another embodiment, themedication pellets have a length of 13 mm and a diameter of 5 mm. Inanother embodiment, the medication pellets have a length of 13 mm and adiameter of 5.6 mm. Female testosterone pellets may include 50 mg to 150mg, with lengths ranging from 5 mm to 15 mm, and diameters ranging from2 mm to 5 mm. In an illustrative embodiment, the female testosteronepellet is 87 mg with a 10 mm length and 3 mm diameter. In oneembodiment, the cannula may be sized for 5 mm medication pellets formale hormone replacement therapy, e.g. the interior diameter of thecannula is greater than 5 mm. In another embodiment, the cannula may besized for 4 mm medication pellets for male hormone replacement therapy,e.g. the interior diameter of the cannula is greater than 4 mm and lessthan 6 mm. In still another embodiment, the cannula may be sized for 3mm medication pellets for female hormone replacement therapy, e.g. theinterior diameter of the cannula is greater than 3 mm and less than 4mm.

The illustrative cannula 200 may further include a cannula handle 210fixedly coupled to the tubular cannula body 202. The cannula handle 210may be permanently affixed to the exterior of the tubular cannula body202, such as by welding, or removably affixed to the tubular cannulabody 202, such as by threading or chemical means. Further, the tubularcannula body 202 and the cannula handle 210 may be machined from asingle piece.

By way of example and not of limitation, each of the components of theminimally traumatic trocar apparatus, system and kit may be formed frommetallic compounds, metal alloys, plastic materials, polymers or othersuch materials. The material selected for the minimally traumatic trocarmay depend upon whether the minimally traumatic trocar is disposable ornon-disposable (reusable). For example, a reusable minimally traumatictrocar apparatus may be constructed from stainless steel so that it canbe disinfected in an autoclave. While a disposable minimally traumatictrocar may be composed of a plastic material, such as an extrudedplastic, that is intended for single use and is disposal. The extrudedplastic may be high grade medical plastic, polystyrene (HIPS),acrylonitrile butadiene styrene (ABS), polypropylene (PP), high, low, orlinear low density polyethylene (HDPR, LDPE, LLDPE), rigid polyvinylchloride (PVC), thermoplastics. Further, the extruded plastic may benon-toxic, free of lead, resistant to chemicals, high temperatures(i.e., sterilization temperatures), high wear, and corrosion resistant.

The illustrative cannula 200 may further include an illustrative notch212 located at the posterior end of the tubular cannula body 202. In theillustrative embodiment, the notch 212 is hyperbolic, rectangular, ortriangular in shape and configured to interface with a correspondinglyshaped tab on an obturator inserted into the interior passage of thecannula 200, as described below. In a further embodiment, theillustrative cannula 200 may include a second notch (not shown) in asecond position at the posterior end of the tubular cannula body 202.

The illustrative cannula 200 may further include one or more cannulamarkings 214 along the tubular cannula body 202. In various embodiments,the cannula markings 214 are visible on the exterior of the tubularcannula body 202. Visibility of the cannula markings 214 may be achievedby scoring, embossing, raising, or coloring. Coloring may include paint,ink, anodizing, or other similarly permanent and visible techniquessuitable for use in sterile operations. Where the cannula markings 214are not scored, embossed, or raised, the cannula markings 214 may beflush with the exterior of the tubular cannula body 202. The cannulamarkings 214 correspond to a medication length, and serve to aid adoctor or assistant in determining the number of medication pellets oramount of medications administered through the cannula 200. In theillustrative embodiment, the markings 214 are laser etched onto thesurface of the cannula 200. In another embodiment, the cannula 200 mayinclude only a single marking 214.

By way of example and not of limitation, the cannula markings 214 may bescored on the surface of an illustrative stainless steel cannula.Alternatively, for a plastic cannula, the cannula markings may beembodied as raised bars, sunk depressions, or flush colored sections onthe exterior of the cannula body.

More generally, the illustrative cannula 200 has a total length that mayrange from 13 centimeters up to 17 centimeters. The total cannula lengthis measured from the anterior cannula opening 204 to the posteriorcannula opening 206. The cannula 200 also has an insertion length thatmay range from 7 cm to 13 cm. In one embodiment, the cannula 200 has aninsertion length of 10 cm. In various embodiments, the tubular cannulabody 202 may have an outer diameter ranging from 7 mm down to 3 mm, andan inner diameter ranging from 2 mm to 6 mm. In narrower embodiments,the outer diameter of the tubular cannula body ranges from 6 mm to 7mm,and the inner diameter ranges from 5 mm to 6 mm. In another narrowerembodiment, the outer diameter of the tubular cannula body is 3 mm to 4mm, and the inner diameter ranges from 2 mm to 3 mm.

In these embodiments, the wall thickness of the tubular cannula bodyranges from 2 mm to 1/10 mm. In the illustrative example, the tubularcannula body is composed of stainless steel and has an outer diameter 5½mm and an inner diameter of 5 mm; thus, the wall thickness of thetubular cannula body is a ½ mm. Additionally, the illustrative tubularcannula body has a length of between 14 cm and 16.5 cm. In a narrowerembodiment, the tubular cannula body length ranges from 15 cm up to 15.6cm. In an even narrower embodiment, the tubular cannula body length is15.4 cm.

Referring now to FIG. 2B, there is shown an illustrative embodiment ofan obturator 220 having a tubular obturator body 222, an anteriorrounded tip 224, a posterior obturator opening 226, and one or moremedication delivery markings 227 along the tubular body of the obturator222. The tubular obturator body 222 is hollow from the anterior roundedtip 224 to and through the posterior obturator opening 226. By way ofexample and not of limitation, the illustrative obturator has a lengthof between 7 inches and 8 inches, an outer diameter of between 6 mm and2.8 mm, an inner diameter of between 5.7 mm and 2.5 mm, and a wallthickness of between 0.1 mm and 0.5 mm. In a narrower embodiment, theobturator has a length of between 7.25 inches and 7.75 inches, an outerdiameter of between 6 mm and 5.5 mm, and an inner diameter of between5.7 mm and 5.2 mm. In another narrower embodiment, the obturator has alength of between 7 inches and 7.5 inches, an outer diameter of between4.1 mm and 3.6 mm, and an inner diameter of between 3.8 mm and 3.3 mm.In an even narrower embodiment, the obturator length is 7.5 inches, theouter diameter is 4.8 mm, and the inner diameter is 4.3 mm; thus, thewall thickness for the obturator is ½ mm.

Thus, in a broad embodiment, the tolerance between the outer diameter ofthe obturator and the inner diameter of the cannula is 0.05 inches. In anarrower embodiment, the tolerance between the outer diameter of theobturator and the inner diameter of the cannula is 0.01 inches. In aneven narrower embodiment, the tolerance between the outer diameter ofthe obturator and the inner diameter of the cannula is 0.001 inches. Andin a still narrower embodiment, the tolerance between the outer diameterof the obturator and the inner diameter of the cannula is 0.0005 inches.

The anterior rounded tip 224 comprises a blunt surface. The bluntsurface formed by the anterior cannula end and anterior blunt tip of theobturator 240 may be a continuous smooth surface or a semi-continuoussmooth surface. The anterior rounded tip 224 may be a rounded cone, aflat-topped cone, a spherical cap, or a semi-spherical cap. A similarlycontinuously smooth or semi-continuously smooth blunt surface or edgemay be formed by the blunt anterior cannula end and the anterior blunttip of the obturator. In the illustrative embodiment, the blunt surfaceincludes rounded or beveled edges of the anterior end of the cannula.The combination of the anterior cannula end and the blunt anterior tip224 of the obturator 220 is blunt or rounded to reduce or preventinstances of tissue tearing during the subcutaneous pellet insertionprocedure.

The medication delivery markings 227 along the tubular body of theobturator 222 aid in delivery of medication pellets from the cannula 200to a delivery site. In various embodiments, the delivery markings 227are visible on the exterior of the tubular body of the obturator 222.Visibility of the delivery markings 227 may be achieved by scoring,embossing, or coloring. Coloring may include paint, ink, anodizing, orany suitable flush marking technique. Where the delivery markings 227are not recessed or scored, the delivery markings 227 may be flush withthe exterior of the tubular body of the obturator 222. The deliverymarkings 227 correspond to a medication length, and serve to aid asurgeon, nurse, physician's assistant, or other medical professional indetermining the number of medications or amount of medicationsadministered through the cannula 200 with the obturator 220. In oneembodiment, the delivery markings 227 correspond to a medication lengthof ½ inch. In a further embodiment, the delivery markings correspond tocannula markings 214 that are also spaced ½ inch apart from one another.In another embodiment, the delivery markings 227 correspond to amedication length of 1 cm. In this other embodiment, the deliverymarkings correspond to cannula markings 214 that are also spaced 1 cmapart from one another. However, in alternative embodiments, thedelivery markings 227 and cannula markings 214 correspond to medicationlengths ranging from 2.5 mm to 18 mm.

The illustrative obturator 220 further includes one or more openings 228located along the tubular obturator body 222. The openings 228 form apassage from the exterior of the tubular obturator body 222 to theinterior of the tubular obturator body 222. In the illustrativeembodiment, the openings 228 are arranged on the obturator 220 from theanterior rounded tip 224 along the entire length of the obturator body222 in a spiral orientation. In other embodiments, the openings 228 maybe located on and about the anterior rounded tip 224. By way of exampleand not of limitation, the openings are approximately 1 mm in diameter.In various embodiments, the openings can range in diameter from ¼ mm upto 2.5 mm.

The openings 228 enable the obturator to more easily separate thesubcutaneous tissue, adipose tissue, blood vessels, and nerves throughhydrodissection. Hydrodissection is a well-known technique inophthalmologic surgery and general surgery where a fluid, such as salineis injected into a target tissue to create a previously non-existentsurgical plane. In ophthalmologic surgery hydrodissection is used tocreate space within the lens, thereby improving a surgeon's ability toperform maneuvers during extracapsular or phacoemulsification surgeries.In general surgery, hydrodissection is used in conjunction withultrasonic guidance to treat peripheral nerve entrapments by releasingthe nerves' adhesions from neighboring structures. When releasingentrapped nerves with hydrodissection the fluid used may beplatelet-rich plasma (“PRP”) or a 5% dextrose solution (“D5W”). In theillustrative embodiments disclosed herein the hydrodissecting fluiddelivered through the openings 228 includes PRP, D5W, saline,anesthetic, a numbing solution, lidocaine, epinephrine, antifibrinolyticcompounds (i.e., tranexamic acid), or any combination thereof. In otherembodiments, the hydrodissecting fluid includes 0.1 to 2 partstranexamic acid, 8 to 9.9 parts 1% lidocaine solution, and 1/1,000,000to 1/1,000 parts epinephrine. In a narrower embodiment, thehydrodissecting fluid includes 1 mL tranexamic acid, 9 mL 1% lidocainesolution, and 1/100,000 epinephrine (i.e., 1 g epinephrine in 100,000 mLhydrodissecting solution).

Hydrodissection during the minimally traumatic subcutaneous pelletdelivery systems and methods disclosed herein allows the obturator toseparate the subcutaneous tissue, adipose tissue, blood vessels, andnerves prior to arrival of the anterior blunt tip of the obturator. Thispreparation of the tissue into which the minimally traumatic trocar isinserted softens, hydrates, and/or superhydrates the tissue, easing andimproving the maneuverability of the minimally traumatic trocar withinthe tissue. Additionally, where the hydrodissection fluid includeslidocaine or other numbing agents, the hydrodissection fluid operates tonumb the tissue and/or block nerves along the insertion path, whichreduces a patient's pain level during and immediately after medicationpellet insertion with only minimal amounts of micro-traumatic. Where thehydrodissection fluid includes epinephrine, the hydrodissection fluidoperates to constricts the blood vessels and reduce bleeding from anytissue punctured, torn, or irritated along the insertion path. Where thehydrodissection fluid includes an antifibrinolytic compound, such astranexamic acid, the hydrodissection fluid operates to slow thebreakdown of any blood clots that form along the insertion path, whichreduces or prevents prolonged bleeding from minimally traumaticmedication pellet insertion.

The illustrative obturator 220 may further include an obturator handle230 fixedly coupled to the tubular obturator body 222. The obturatorhandle 230 may be integral to the tubular obturator body 222;permanently affixed to the exterior of the tubular obturator body 222,such as by welding, glue, or epoxy; or removably affixed to the tubularobturator body 222, such as by threading or chemical means.

Further still, the illustrative obturator 220 may include a tab 232configured to interface with the notch 212 on the posterior end of thecannula 200. The tab 232 may be located adjacent to the obturator handle230 and may be located on the exterior surface of the obturator tubularbody 222. The tab 232 may be raised above the exterior surface of theobturator tubular body 222. The tab 232 is fixedly coupled to one of theobturator handle 230 and the obturator tubular body 222. In variousembodiments, the tab 232 and the obturator handle 230 are formed from asingle machined piece. In some embodiments, the obturator 220 includes asecond tab 233 located at a second position about the exterior surfaceof the obturator tubular body 222.

In a broad embodiment, the tolerance between the notch 212 and the tab232 is 0.05 inches. In a narrower embodiment, the tolerance between thenotch 212 and the tab 232 is 0.01 inches. In an even narrowerembodiment, the tolerance between the notch 212 and the tab 232 is 0.001inches. And in a still narrower embodiment, the tolerance between thenotch 212 and the tab 232 is 0.0005 inches.

The insertion obturator 220 may further include a threaded posterior end234. The threaded posterior end 234 may be configured to receive amedication, numbing solution, anesthetic, and/or hydrodissecting fluidthrough a tubing from a syringe pump or other reservoir. By way ofexample and not of limitation, the threaded posterior end 234 includes aluer lock receptor, which is configured to interface with tubing thatdelivers a numbing solution, anesthetic, and/or hydrodissecting fluid.The numbing solution may include saline, lidocaine, and/or epinephrine.The tubing can be plastic, rubber, flexible, or rigid. In someembodiments, the threaded posterior end 234 surrounds the posteriorobturator opening 226.

More generally, the illustrative obturator 220 has a total length thatmay range from eighteen (18) centimeters up to twenty-two (22)centimeters, and an insertion length that may range from 15 cm up to 19cm. The total obturator length is measured from the anterior point ofthe anterior rounded tip 224 to the posterior obturator opening 226. Theinsertion length is measured from the anterior point of the anteriorrounded tip 224 to the anterior surface of the obturator handle 230. Inone embodiment, the total obturator length is 19 cm and the insertionlength is 16 cm.

In various embodiments, the obturator 220 is a single stainless steel ortitanium piece, with no weak joints susceptible to failure. Thus, noelement of the obturator 220 is likely to break or separate from a mainbody of the obturator and remain inside a patient's dermis or othercavity.

Referring now to FIG. 2C, there is shown the illustrative obturator 220inserted into the interior passage of the illustrative cannula 200 toform a non-disposable minimally traumatic trocar 240, in which theportion of the obturator tubular body 222 within the interior passage ofthe cannula 200 is shown with dotted lines.

In the illustrative embodiment, the obturator 220 is long enough incomparison to the cannula 200, that the rounded tip 224 and at least oneopening 228 protrude beyond the anterior end of the cannula 200 andthrough the anterior cannula opening 204 when the obturator 220 isinserted into the cannula 200 so that the tab 232 interfaces with thenotch 212. In this illustrative embodiment, the rounded tip 224 mayprotrude up to 1 cm beyond the anterior end of the cannula 200 so thatthe rounded tip 224 separates tissue up to approximately 1 cm distal orin front of the anterior end of the cannula 200 with minimalmicro-trauma upon insertion of the assembled trocar through an incisionsite to an insertion site. This additional length of the obturator 220modifies tissue so that a later inserted medication pellet can beextruded further into the tissue, for example by tunneling themedication pellet through the tissue displaced by the additional lengthof the obturator 220 extending beyond the anterior end of the cannula200.

In another embodiment, the obturator 220 is long enough in comparison tothe cannula 200, that only the anterior rounded tip 224 protrudes beyondthe anterior end of the cannula 200 and through the anterior cannulaopening 204 when the obturator 220 is inserted into the cannula 200 sothat the tab 232 interfaces with the notch 212.

In other embodiments, the obturator 220 is long enough in comparison tothe cannula 200, that the rounded tip 224 and at least one opening 228protrude beyond the anterior end of the cannula 200 and through theanterior cannula opening 204 when the obturator 220 is inserted into thecannula 200 so that the obturator handle 230 abuts the posterior cannulaend.

Referring now to FIG. 3A, there is shown an illustrative obturatoranterior rounded tip 224 a having seven (7) openings 228 a. Theillustrative openings 228 a may be proximate to the anterior point ofthe rounded tip 225 a and arrayed in a spiral pattern along the tubularbody of the obturator 222, such that a second opening is 1 cm furtherfrom the anterior point of the rounded tip 225 a than a first openingand radially separated from the first opening by an angle of 30 degrees.This separation may be greater, such as 2 cm and 60 degrees, or anycombination of these linear and radial separations. Generally, thespiral pattern is achieved by continuation of the same separation fromthe second opening to a third opening as that from the first opening tothe second opening. The openings 228 a pass through the outer surface ofthe obturator to the interior. In an alternative embodiment, theopenings 228 a are arrayed in a circular pattern about the anteriorrounded tip 224 a, such that the openings 228 a are in a planeperpendicular to the length of the obturator 220. In this alternativeembodiment, the openings 228 a are located in proximity to the anteriorpoint of the rounded tip 225 a, such as within 2 cm of the anteriorpoint of the rounded tip 225 a. In a modification of this alternativeembodiment, the openings 228 a are arrayed in a plane perpendicular tothe length of the obturator 220, and located within 1 cm of the anteriorpoint of the rounded tip 225 a. In these alternative embodiments, theopenings 228 a are arrayed such that none of the openings 228 a aresituated along the tubular obturator body 222 and all of the openings228 a are equally distal, proximate, or distant from the anterior pointof the rounded tip 225 a.

Referring now to FIG. 3B, there is shown another illustrative obturatoranterior rounded tip 224 b having five (5) openings 228 b. Theillustrative openings 228 b may be proximate to the anterior point ofthe rounded tip 225 b and are arrayed in a spiral pattern along thetubular body of the obturator 222. The openings 228 b pass through theouter surface of the obturator to the interior. In an alternativeembodiment, the openings 228 b are arrayed in a circular pattern aboutthe anterior rounded tip 224 b, such that the openings 228 b are in aplane perpendicular to the length of the obturator 220. In thisalternative embodiment, the openings 228 b are located in proximity tothe anterior point of the rounded tip 225 b, such as within 2 cm of theanterior point of the rounded tip 225 b. In a modification of thisalternative embodiment, the openings 228 b are arrayed in a planeperpendicular to the length of the obturator 220, and located within 1cm of the anterior point of the rounded tip 225 b. In these alternativeembodiments, the openings 228 b are arrayed such that none of theopenings 228 b are situated along the tubular obturator body 222 and allof the openings 228 b are equally distal, proximate, or distant from theanterior point of the rounded tip 225 b.

Referring now to FIG. 3C, there is shown a side view of the illustrativeobturator anterior rounded tip 224 a and some of its seven (7) openings228 a arrayed in a plane perpendicular to the length of the obturator.Three (3) of the openings 228 a are in view, one (1) opening 229 ispartially in view, and the remaining three (3) openings are not visibleon the reverse side of the obturator. In this illustrative embodiment,the openings 228 are set back from the terminus of the tip 224 andentirely located on the tubular obturator body instead of any roundedportion of the tip 224.

With reference now to FIG. 3D, there is shown another illustrativeobturator anterior rounded tip 224 d having two (2) openings 228 d. Theillustrative openings 228 d may be proximate to the anterior point ofthe rounded tip 225 d and are arrayed in a plane perpendicular to thelength of the obturator 220. The openings 228 d are located in proximityto the anterior point of the rounded tip 225 d, such as within 2 cm ofthe anterior point of the rounded tip 225 d. In another embodiment, theopenings 228 d are arrayed in a plane perpendicular to the length of theobturator 220, and located within 1 cm of the anterior point of therounded tip 225 d. In these embodiments, the openings 228 d are arrayedsuch that none of the openings 228 d are situated along the tubularobturator body 222 and all of the openings 228 d are equally distal,proximate, or distant from the anterior point of the rounded tip 225 d.

Referring now to FIG. 3E, there is shown a side view of the illustrativeobturator anterior rounded tip 224 d and one (1) of its two (2) openings228 d arrayed in a plane perpendicular to the length of the obturator.The one opening not shown is not visible on the reverse side of theanterior rounded tip 224 d. In this illustrative embodiment, theopenings 228 are set back from the terminus of the tip 224 and locatedon rounded portion of the tip 224, instead of being partially orentirely located on the tubular obturator body.

As the number of openings proximate to the obturator anterior roundedtip 224 increase, the strength and durability of the tip 224 decreases.Therefore, certain embodiments may include fewer openings, such as one,two, three, or four openings. The reduced number of openings increasesthe structural integrity of the obturator 220, and in particular theanterior rounded tip 224 of the obturator 220. A further attribute ofreducing the number of openings is an increased pressure of numbingsolution or anesthetic delivered through the opening(s). As describedbelow, increasing the delivery pressure of the numbing solution mayimprove hydrodissection, which has the advantageous effect of softeningtissues and creating a surgical plane or fluid channel into whichpellets are delivered.

With reference now to FIG. 4A, there is shown an illustrative cannula200 receiving a medication pellet 104 at the medication slot 208. Thereceived medication pellet 104 resides within the interior passage ofthe cannula 200. By way of example and not of limitation, the medicationslot 208 ranges in length from 0.6 inches down to 0.35 inches. In anillustrative embodiment, the medication slot 208 is 14 mm long and isconfigured to receive a ½ inch (13 mm) long medication pellet.

Referring now to FIG. 4C, there is shown the illustrative obturator 220inserted into the interior passage of the illustrative cannula 200 suchthat at least one medication pellet 104 passes through the anterioropening of the cannula 200. The portion of the obturator tubular body222 within the interior passage of the cannula 200 is shown with dottedlines. The obturator 220 is long enough in comparison to the cannula 200that the anterior blunt tip 224 is of sufficient length to pass themedication pellet(s) through the cannula.

For example, the obturator 220 may extend up to one (1) centimeterbeyond the anterior end of the cannula 200. In this embodiment, theobturator is long enough to push one or more pellets 104 to and throughthe anterior cannula opening 204.

In another embodiment, the obturator 220 is only long enough incomparison to the cannula 200 that the anterior blunt tip 224 is flushwith the anterior end of the cannula 200 and the anterior cannulaopening 204 when the obturator 220 is inserted into the cannula 200 to amaximum allowable extent. The maximum allowable extent is the point atwhich the obturator handle 230 abuts the posterior cannula opening 206and the posterior end of the cannula 200.

The minimally traumatic trocar apparatus described above may be embodiedin a kit that includes the cannula 200, the obturator 220, ahydrodissection microcannula, and an outer package that houses thecannula, obturator, and hydrodissection microcannula. By way of exampleand not of limitation, the illustrative minimally traumatic trocar kitmay also include a scalpel, scissors, forceps, bandages, a sterile fielddrape, gauze, antiseptic ointments, a wound closure component, and othersuch materials that may be used during the medical procedure. Thescalpel may include the illustrative punch scalpel described below. Inanother embodiment, the kit includes a disposable trocar as describedbelow.

Referring now to FIG. 5A, there is shown a top view of an illustrativedisposable obturator 500 having a tubular body 502, an anterior roundedtip 504, and one or more medication delivery markings 506 along thetubular body of the obturator 502. The illustrative disposable obturator500 also includes one or more tabs 508 and a textured handle 510. In theillustrative embodiment, the tubular body 502 is of a solid constructionwith structural ribs representing or performing the secondary functionof the medication delivery markings 506. This solid constructionprevents the disposable obturator 500 from being hollow or deliveringhydrodissection fluid. The illustrative disposable obturator may becomposed of a plastic material, such as an extruded plastic, that isintended for single use and is disposal. The extruded plastic may behigh grade medical plastic, polystyrene (HIPS), acrylonitrile butadienestyrene (ABS), polypropylene (PP), high, low, or linear low densitypolyethylene (HDPR, LDPE, LLDPE), rigid polyvinyl chloride (PVC),thermoplastics. Further, the extruded plastic may be non-toxic, free oflead, resistant to chemicals, high temperatures (i.e., sterilizationtemperatures), high wear, and corrosion resistant.

By way of example and not of limitation, the illustrative disposableobturator has a length from the anterior tip 504 to the textured handle510 of between 4 inches and 7 inches and an outer diameter of between 6mm and 3 mm. In a narrower embodiment, the obturator has a length ofbetween 4½ and 5 inches and an outer diameter of between 3.3 mm and 3.7mm. In one embodiment, the obturator length is 4.8 inches and the outerdiameter is 3.5 mm. In another narrow embodiment, the obturator has alength of between 6 and 6.7 inches and an outer diameter of between 4½mm and 6 mm. In one embodiment, the obturator length is 6.3 inches andthe outer diameter is 4.9 mm. In another embodiment, the obturatorlength is 6.4 inches and the outer diameter is 5.6 mm.

The anterior rounded tip 504 may have substantially the same shape asthe non-disposable anterior rounded tip 224 described in FIGS. 2B, 2C,3A, 3B, 3C, 3D, 3E. Thus, the anterior rounded tip 224 comprises a bluntsurface that may be a continuous smooth surface or a semi-continuoussmooth surface.

The textured handle 510 has a honeycombed structure that simultaneouslyreduces the amount of material required to form the handle and providestexture for gripping the handle. The solid structure of the obturatorprevents delivery of hydrodissecting fluid through the obturator duringinsertion of the assembled disposable trocar into the subcutaneoustissue. However, this solid construction also obviates the need of aluer lock receptor on the posterior portion of the obturator handle, andprovides the user with a more ergonomic grip that is easier for the userto manipulate during subcutaneous insertion.

With reference now to FIG. 5B, there is shown a perspective view of theillustrative disposable obturator 500. In this view, a depth or reliefof the structural ribs or medication markings 506 can be seen. Thisdepth or relief represents negative space formed as a result of thestructure of the disposable obturator 500. In the illustrativeembodiment, the tubular body 502 of the disposable obturator is formedfrom two linear bars running lengthwise and oriented perpendicular toone another. These linear bars are supported by the medication markingribs 506, which are oriented orthogonal to the two linear bars, i.e.perpendicular to each linear bar.

This view also shows the height and orientation of two tabs 508 adjacentto the textured handle 510. These tabs 508 are oriented with a long axisrunning parallel to the length of the disposable obturator tubular body502. Further, the tabs 508 are located radially about an outer surfaceof the disposable obturator tubular body 502, such that the tabs areradially separated from one another by 180°. In other embodiments, feweror greater than two tabs 508 are included on the disposable obturator.The orientation of the tabs 508 may be such that they are radiallyequidistant about the surface of the disposable obturator tubular body502 from each other, i.e. three tabs are separated by 120° each, fourtabs are separated by 90° each, and so on. In other embodiments, thetabs 508 may be oriented radially non-equidistant from one another aboutthe surface of the disposable obturator tubular body 502.

This view further shows the hollow recesses forming the honeycombedstructure of the textured handle 510. These hollow recesses may extendfully through the textured handle 510. In another embodiment, thesehollow recesses may not extend fully through the textured handle 510,but instead stop at a solid division within the textured handle 510 thatseparates a top side of the textured handle 510 from a bottom side ofthe textured handle 510. In some embodiments, the texture arises fromcavities or depressions and ridges on the surface of the textured handle510.

Referring now to FIG. 6A, there is shown an illustrative disposablecannula 600, having a tubular cannula body 602. The tubular cannula body602 includes an anterior cannula opening 604 located at an anterior end606 of the disposable cannula 600. The anterior end 606 of thedisposable cannula 600 includes a blunt or rounded cylindrical end,which limits the trauma to surrounding tissue during subcutaneousimplant procedure. In one embodiment, the cylindrical end of the cannulais blunted by beveling the end. The bevel blunts the cylindrical end ofthe cannula in this structure, because the beveled edge abuts the outersurface of the obturator tubular body and lies flush or very nearlyflush against this outer surface. This blunting may also be achievedwith a chamfer, a fillet, rounding to create a rounded shape, or anyother method of smoothing the right angle where the outer surface of thetubular body of the cannula meets the cylindrical end of the cannula.The tubular cannula body 602 further includes a posterior cannulaopening 608 located at a posterior end 610 of the disposable cannula600. The tubular cannula body 602 is hollow, providing a passage throughthe disposable cannula 600 and connecting the anterior cannula opening604 to the posterior cannula opening 608. Thus, the tubular cannula body602 includes an interior passage disposed between the posterior cannulaend 608 and the anterior cannula end 604.

In the illustrative embodiment, the posterior end 610 of the disposablecannula 600 includes one or more notches 612 configured to interface orinterlock with one or more tabs 508 of the disposable obturator 500 uponfull insertion of the disposable obturator 500 into the interior passageof the disposable cannula 600. In illustrative embodiment, the one ormore notches 612 are located at the posterior end 610 of the tubularcannula body 602. The one or more notch 612 may be hyperbolic,rectangular, or triangular in shape and configured to interface with thecorrespondingly shaped tab 508 of the disposable obturator 500. In theillustrative embodiment, two notches 612 are located radially around theposterior end 610 of the tubular cannula body 602, such that the notches612 are radially separated from one another by 180°. In otherembodiments, fewer or greater than two notches 612 are included on thedisposable cannula 600. The orientation of the notches 612 may be suchthat they are radially equidistant around the posterior end 610 of thetubular cannula body 602 from each other, i.e. three notches areseparated by 120° each, four notches are separated by 90° each, and soon. In other embodiments, the notches 612 may be oriented radiallynon-equidistant from one another about the posterior end 610 of thetubular cannula body 602. In all embodiments, the one or more notches612 are oriented to correspond to the orientation of one or morecorresponding tabs 508 of the disposable obturator 500.

In the illustrative embodiment, the disposable cannula 600 furtherincludes a medication slot 614 on a portion of the tubular cannula body602. The slot 614 is configured or sized to receive a medication pelletand thereby allow the medication pellet access to the interior passageof the disposable cannula 600. The slot 614 may be located anywherealong the tubular body 602 of the disposable cannula 600, such as moreproximate to the posterior end 610 of the disposable cannula 600 than atextured handle 616. The textured handle 616 includes hollow recessesforming a honeycombed structure. These hollow recesses may extend fullythrough the textured handle 616. In another embodiment, these hollowrecesses may not extend fully through the textured handle 616, butinstead stop at a solid division within the textured handle 616 thatforms part of the interior passage of the disposable cannula 600. Insome embodiments, the texture arises from cavities or depressions andridges on the surface of the textured handle 616.

The textured handle 616 may be fixedly coupled to the tubular cannulabody 602. The textured handle 616 may be permanently affixed to theexterior of the tubular cannula body 602, removably affixed to thetubular cannula body 602, such as by a snap, clip, collar, threading orchemical means, or may be integral to the disposable cannula 600. Thus,the tubular cannula body 602 and the textured handle 616 may be moldedas a single piece.

In the illustrative embodiment, the textured handle 616 and the portionsof the disposable cannula located posterior to the textured handle 616,such as the medication slot 614 and posterior cannula end 610,collectively comprise a posterior portion of the disposable cannula 600,while the tubular cannula body 602 comprises an anterior portion of thedisposable cannula 600. The posterior portion may be constructed of aplastic material, such as an extruded plastic, that is intended forsingle use and is disposable, while the anterior portion of thedisposable cannula may be constructed from metal, such as aluminum,titanium, or stainless steel. The extruded plastic may be high grademedical plastic, polystyrene (HIPS), acrylonitrile butadiene styrene(ABS), polypropylene (PP), high, low, or linear low density polyethylene(HDPR, LDPE, LLDPE), rigid polyvinyl chloride (PVC), thermoplastics.Further, the extruded plastic may be non-toxic, free of lead, resistantto chemicals, high temperatures (i.e., sterilization temperatures), highwear, and corrosion resistant. The posterior and anterior portions ofthe disposable cannula may be removably coupled to one another with asnap, clip, collar, or threading.

In the illustrative embodiment, the disposable cannula 600 furtherincludes one or more cannula marking 618 along the tubular cannula body602. In various embodiments, the cannula markings 618 are visible on theexterior of the tubular cannula body 602. Visibility of the cannulamarkings 618 may be achieved by scoring, embossing, raising, orcoloring. Coloring may include paint, ink, anodizing, or other similarlypermanent and visible techniques suitable for use in sterile operations.Where the cannula markings 618 are not scored, embossed, or raised, thecannula markings 618 may be flush with the exterior of the tubularcannula body 602. The cannula markings 618 correspond to a medicationlength, and serve to aid a doctor or assistant in determining the numberof medications or amount of medications administered through thedisposable cannula 600. In one embodiment, the cannula markings 618 maybe embodied as sunk depressions.

With reference now to FIG. 6B, there is shown the disposable cannula 600from a side view. This side view shows ergonomic contours on thetextured handle 616 designed to conform more closely to an operator'sthumb, fingers, and hand. These ergonomic contours in combination withthe texture of the handle 616 improve an operator's grip and comfortwhen handling and using the disposable cannula 600. This view also showsthat the outer diameter of the posterior portion of the cannula islarger than the outer diameter of the anterior portion. This disparityin outer diameter size arises from the construction materials used forthe illustrative example. In the illustrative cannula, the anteriorportion comprises a tube of metal fabrication, while the posteriorportion is medical grade plastic. The medical grade plastic constructionmay require thicker walls, such that an interior diameter that matchesfor the anterior and posterior portions of the disposable cannula 600requires that the outer diameter of the posterior portion be larger thanthat of the anterior portion.

By way of example and not of limitation, the illustrative disposablecannula 600 has a length from the anterior end 606 to the texturedhandle 616 of between 2 inches and 5 inches, an outer diameter ofbetween 7 mm and 4 mm, and an inner diameter of between 6 mm and 3 mm.In a narrower embodiment, the disposable cannula has a length of between4½ and 3½ inches, an outer diameter of between 7 mm and 5 mm, and aninner diameter of between 6 mm and 4½ mm. In one embodiment, thedisposable cannula length is 4 inches, the outer diameter is 6.6 mm, andthe inner diameter is 5.8 mm. In another embodiment, the disposablecannula length is 4 inches, the outer diameter is 5½ mm, and the innerdiameter is 5 mm. In another narrow embodiment, the disposable cannulahas a length of between 3 and 2 inches, an outer diameter of between 4½mm and 4 mm, and an inner diameter of between 4 mm and 3½ mm. In oneembodiment, the disposable cannula length is 2½ inches, the outerdiameter is 4.2 mm, and the inner diameter is 3.7 mm.

Referring now to FIG. 6C, there is shown a perspective view of thedisposable cannula 600. This view shows the depth of the hollowscomprising the texture of the textured handle 616 and the wall thicknessof the posterior portion of the disposable cannula (particularly at themedication slot 614). Additionally, this view shows where the texturedhandle 616 overlaps with the tubular cannula body 602 in order tofacilitate coupling the anterior portion of the disposable cannula andthe posterior portion of the disposable cannula. In some embodiments,the snap, clip, collar, or threading are internal to the textured handle616 that couple the textured handle 616 and posterior portion of thedisposable cannula to the tubular cannula body 602 and anterior portionof the disposable cannula.

FIG. 7 shows the disposable cannula 600 and disposable obturator 500assembled into a disposable minimally traumatic trocar 700. The outerdiameter of the tubular obturator body 502 is sized and configured tofit within the interior passage of the disposable cannula tubular body602 by being 0.001 inches to 0.02 inches less than the inner diameter ofthe disposable cannula tubular body 602. In the illustrative embodiment,the tolerance (or difference) between the inner diameter of thedisposable tubular cannula body 602 and the outer diameter of thedisposable tubular obturator body 502 is 0.006 inches. As describedabove, the solid structure of the obturator obviates the need of a luerlock receptor on the posterior portion of the obturator handle, andprovides the user with a more ergonomic grip which makes it easier forthe user to manipulate the assembled disposable trocar 700 duringsubcutaneous insertion.

With reference now to FIG. 8, there is shown an infusion cannula or ahydrodissection microcannula 800. The hydrodissection microcannula 800includes an attachment hub 802, a shaft 804, and a tip 806. Theattachment hub 802 serves to couple the hydrodissection microcannula 800to a syringe containing a hydrodissection fluid. The attachment hub 802may include a female luer lock fitting, a polypropylene slip hub, orother comparable fitting for connecting the hydrodissection microcannula800 to a syringe. The shaft 804 may comprise a medical grademicrocannula ranging from 10 gauge (outer diameter=3.4 mm; innerdiameter=2.7 mm) down to 30 gauge (outer diameter=3.1 mm; innerdiameter=0.16 mm), and have a length ranging from 8 cm to 15 cm. In oneembodiment, the hydrodissection microcannula 800 has a length of 10 cm.In another embodiment, the hydrodissection microcannula 800 has a lengthof 12 cm. The shaft 804 is a hollow tube constructed from biocompatible,pharmacologically inert, non-toxic materials, such as medical gradeplastics, stainless steel, carbon steel, nickel plated, and anycombination thereof. In the illustrative embodiment, the shaft 804 is a14 gauge stainless steel construct that is 15 cm long. The tip 806 ofthe hydrodissection microcannula has an anterior opening or port to thehollow interior of the shaft, and a blunt shape lacking a sharp,beveled, or incising point. Without a surface for a bevel to lie flushagainst, the bevel would act as a sharp cutting edge. In one embodiment,the hydrodissection microcannula 800 is a polydioxanone (PDO) threadmicrocannula. In another embodiment, the hydrodissection microcannula800 is a microcannula.

FIGS. 9A-D shown various types of blunt tip embodiments for thehydrodissection microcannula 800. These types of microcannula tipsrequire an existing incision through the skin into the subcutaneoustissue in order to penetrate along an insertion path and deliverhydrodissection fluid despite a narrow gauge shaft. FIG. 9A shows amicrocannula shaft 900 having a flat blunt tip 902 that forms a 90°angle with the length of the shaft 900. The port or opening forhydrodissection fluid is the anterior surface of the tip 902, which isopen to the hollow shaft interior.

FIG. 9B shows a microcannula shaft 910 having a conical taper 912 to aflat blunt tip 914 that forms a 90° angle with the length of the shaft910, but forms an acute angle with the outer surface of the conicaltaper 912. The port or opening for hydrodissection fluid is the anteriorsurface of the tip 912, which is open to the hollow shaft interior.

FIG. 9C shows a microcannula shaft 920 having a continuous conical shapecoming to a smooth anterior end forming the tip 922. The continuousconical shape is possible in this type of tip because the port oropening 924 for hydrodissection fluid is not located at the anteriorterminus of the shaft 920. Instead, this type of microcannula shaftincludes the port or opening 924 along the shaft 920, near the anteriorterminus of the tip 922. In some embodiments, the port or opening 924may be situated along the shaft 920 prior to the conical portion of thetip, i.e. situated where the shaft walls are parallel and before theinner and outer diameters begin decreasing to zero at the anteriorterminus of the tip 922. In other embodiments, the port or opening 924may be situated along the shaft 920 where the conical taper of the tip922 begins, thus the port or opening 924 is situated in part where theshaft walls are parallel and in part on the conical portion of the tip922. In still other embodiments, the port or opening 924 is locatedentirely on the conical taper of the tip 922.

FIG. 9D shows a microcannula shaft 930 having a continuous orsemi-continuous conical shape coming to a broad pointed anterior endforming the tip 932. The continuous or semi-continuous conical shape ispossible in this type of tip because the port or opening 934 forhydrodissection fluid is not located at the anterior terminus of theshaft 930. Instead, this type of microcannula shaft includes the port oropening 934 along the shaft 930, near the anterior terminus of the tip932. In some embodiments, the port or opening 934 may be situated alongthe shaft 930 prior to the conical portion of the tip, i.e. situatedwhere the shaft walls are parallel and before the inner and outerdiameters begin decreasing to zero at the anterior terminus of the tip932. In other embodiments, the port or opening 934 may be situated alongthe shaft 930 where the conical taper of the tip 932 begins, thus theport or opening 934 is situated in part where the shaft walls areparallel and in part on the conical portion of the tip 932. In stillother embodiments, the port or opening 934 is located entirely on theconical taper of the tip 932.

With reference now to FIGS. 10A-C, there is shown an illustrative punchscalpel 1000 that includes a bracket 1002 and a scalpel blade 1004.Referring now to FIG. 10A, the punch scalpel 1000 is shown from thefront. The bracket 1002 houses the scalpel blade 1004 and includesridges 1006 for a texture grip that allows a doctor or otherpractitioner to more easily grasp the punch scalpel and thereforeimproves the overall ergonomic design. In some embodiments, the bracketalso includes a base 708 that is perpendicular to the scalpel blade1004, and enables a stable placement of the punch scalpel on a patient'sdermis. In various embodiments, the punch scalpel 1000 can furtherinclude a scalpel handle (not shown) extending beyond the scalpelbracket 1002 above and connected to the scalpel blade 1004. In otherembodiments, the bracket base is the same width as the bracket.

With reference now to FIG. 10B, there is shown the illustrative punchscalpel from a side view. In the illustrative example, the ridges 1006are raised above the surface of the bracket 1002. However, in variousembodiments, the ridges 1006 may be depressed below the surface of thebracket 1002, or be flush with the surface of the bracket 1002 and havea texture that improves or provides a grip. The bracket base 708 extendsbeyond the thickness of the bracket 1002 to create a stable platform fora doctor or other practitioner to brace the punch scalpel against thepatient's dermis. The scalpel blade 1004 has a thickness that is lessthan the thickness of the bracket 1002, in order to allow the bracket1002 to house the scalpel blade 1004.

Referring now to FIG. 10C, there is shown the punch scalpel bracket 1002from below. The punch scalpel bracket 1002 includes guide slot 1010 thathouses the scalpel blade (not shown). Additionally, the base 1008 of thebracket 1002 includes a guide notch 1012 that corresponds to the centerof the scalpel blade and the center of any incision made by the scalpelblade.

With reference now to FIGS. 11A and 11B, there is shown illustrativescalpel blades 1100 and 1110, respectively. Both scalpel blades 1100 and1110 include cutting edges 1102, as well as mounting points 1104 a and1104 b centered within an upper body 1106. Additionally, scalpel blade1100 includes ledge 1108, which is an artifact arising from the greaterwidth of the scalpel blade edge 1102 with respect to the upper body1106. The mounting points 1104 a and 1104 b provide points of attachmentfor a scalpel handle (not shown) or for guides notches/grooves withinthe bracket 1002.

In one embodiment, the minimally traumatic trocar kit is a disposablekit that includes the disposable obturator 500, the disposable cannula600, and instructions informing a user on how to assemble the disposabletrocar and deliver pellets to a subcutaneous delivery site, all housedwithin a disposable packaging. The disposable packaging can be plastic,paper, rigid, flexible, or any combination thereof. In one embodiment,the package is a tray configured to hold the kit elements and apeel-back covering material that seals with the tray, thereby housingthe kit elements. The tray may be plastic, cardboard, layered paper, orany other commercially viable material.

The kit elements may comprise the disposable obturator 500, thedisposable cannula 600, the hydrodissection microcannula 800, a sterilefield drape, antiseptic ointment(s), a syringe, gauze, a scalpel, a cup,forceps, bandages, other wound closure components, and other suchmaterials that may be used during the medical procedure. In an exemplaryembodiment, the syringe is a 10 ml syringe for deliveringhydrodissection fluid. The scalpel can include an 11 blade scalpel orthe punch scalpel 1000. The cup may be plastic, compostable, orotherwise single use. The wound closure components can include butterflystrips, thread and needle (i.e., stitches), or tissue adhesive. Theantiseptic ointments can include chlorhexidine sticks, alcohol swabs,and other disinfectants. In an exemplary embodiment, the bandage is aTegaderm™ transparent film bandage.

With reference now to FIG. 12A, there is shown an illustrative cannula200 loaded with several medication pellets 104 and an illustrativeobturator 220 positioned near the cannula 200 in preparation to deliverthe medication pellets 104 by extruding or forcing the pellets 104through the cannula 200. The length from the most posterior marking 214a on the cannula 200 to the posterior cannula opening 206 and posteriorend of the cannula 200 corresponds to the length from the anterior bluntor rounded tip 224 to the most anterior marking 227 a on the obturator220.

Referring now to FIG. 12B, the obturator 220 is inserted into theinterior passage of the cannula 200 so that the most anterior marking227 a on the obturator 220 are adjacent to the posterior cannula opening206. The portion of the obturator 220 that is within the interiorpassage of the cannula 200 is represented by dotted lines. In thisconfiguration, the blunt tip 224 of the obturator 220 pushes themedication pellets 104 into positions in the interior passage of thecannula 200 corresponding to the cannula markings 214.

Referring now to FIG. 12C, the obturator 220 is inserted into theinterior passage of the cannula 200 so that the second most anteriormarking 227 b on the obturator 220 is adjacent to the posterior cannulaopening 206. When the obturator 220 is inserted into the interiorpassage of the cannula 200 to such a length, the most anterior marking227 a on the obturator 220 is disposed within the interior passage ofthe cannula 200, the blunt tip 224 of the obturator 220 is aligned withthe second most posterior marking 214 b of the cannula 200; and theanterior most medication pellet 104 a passes through the anterioropening 204 of the cannula 200. This causes the anterior most medicationpellet 104 a to be delivered to a delivery site.

With reference now to FIG. 12D, the obturator 220 is inserted into theinterior passage of the cannula 200 to the full length of the obturator220, where the obturator handle 230 abuts the posterior opening 206 ofthe cannula 200. In this configuration, the medication pellets 104 areextruded and delivered even though a portion of the most posteriormedication pellet 104 b remains within the interior passage of thecannula 200. A portion of the most posterior medication pellet 104 bremains within the interior passage of the cannula 200 because thisillustrative obturator embodiment has a length that does not extend theblunt tip 224 of the obturator 220 up to or through the anterior opening204 of the cannula 200 at the anterior end of the cannula 200. Theportion of the most posterior medication pellet 104 b remaining withinthe interior passage of the cannula 200 is represented by dotted lines,while the portion of the most posterior medication pellet 104 b that hasbeen extruded from or through the anterior opening 204 of the cannula200 is represented by solid lines. Notably, in embodiments where theobturator is long enough to extend to and/or through the anterioropening of the cannula 204 the most posterior medication pellet 104 b isfully ejected from the cannula in to the subcutaneous delivery site.This full ejection/extrusion of the most posterior medication pellet 104b also occurs when the obturator 220 used is long enough to extendthrough the cannula 200 and out of the anterior cannula opening 204 wheninserted into the interior passage of the tubular cannula body 202.

An important feature of the systems and apparatus disclosed by FIGS.12A-D is that a single obturator 220 is used to insert the atraumatictrocar as well as extrude medication pellets 104 from the interiorpassage of the cannula 200 for delivery to a delivery site. Notably,prior art trocar apparatus, systems, and methods required the use of aseparate delivery obturator because the angled cutting edge on theinsertion obturator was not suitable to delivering pellets. The angledcutting edge could cause the pellet and insertion obturator to becomestuck in the cannula or shear/shatter the pellet prior to delivery insubcutaneous tissue. However, the rounded anterior tip of the obturator220 disclosed herein allows for delivery of pellets to subcutaneoustissue through the cannula without concerns that the pellets willshatter or become stuck.

Referring now to FIG. 13, there is shown an illustrative insertion area1300 and assembled minimally traumatic trocar 1310 having a centerline1312. The insertion area 1300 is demarcated by the dotted linerepresenting the boundary of an internal cavity of surroundingsubcutaneous tissue, and includes an incision site 1302, an insertionpath 1304, a delivery site 1306, and a delivery area 1308. The assembledminimally traumatic trocar 1310 follows the insertion path 1304 to thedelivery site 1306 by angling the centerline 1312 along an arc 1314during insertion from a right centerline extreme 1312 a to a leftcenterline extreme 1312 b, repeatedly. The insertion path 1304 runsbelow and approximately parallel to the epidermis tissue layer, throughthe dermis and ultimately into the subcutaneous tissue, withoutdescending through or below the fascia into muscle, skeletal, or otherdeeper tissue/organs. The insertion path 1304 may also be described asextending into the incision site 1302, and down through the epidermisand dermis into the subcutaneous tissue. Further still, the insertionpath 1304 may be described as traveling parallel and below the epidermisand dermis, as well as through the and within the subcutaneous tissue.

The precise track of the insertion path 1304 will vary with everyinsertion depending upon the tissue and other connective structuresencountered by the assembled minimally traumatic trocar 1310. Thus, theback-and-forth weaving of the assembled minimally traumatic trocar 1310may oscillate between the right centerline extreme 1312 a and the leftcenterline extreme 1312 b inconsistently, such that the oscillating pathvaries in both frequency and amplitude. For example, a medicalprofessional operating the assembled minimally traumatic trocar 1310 maydirect the assembled minimally traumatic trocar 1310 from the centerlinepath 1312 directly between the right centerline extreme 1312 a and theleft centerline extreme 1312 b somewhat towards the right centerlineextreme 1312 a to bounce off a fibrous septa of tissue, then encounterstill more connective or other tissue impeding the progress of theassembled minimally traumatic trocar 1310 along that path that requiresthe medical professional direct the assembled minimally traumatic trocar1310 further towards the right centerline extreme 1312 a before avoidingstill another portion of denser tissue (such as peripheral somaticnerves or constricted blood vessels, i.e. arterioles or venuoles) whichthen causes the medical professional to direct the assembled minimallytraumatic trocar 1310 back towards the left centerline extreme 1312 b.In this manner the insertion path 1304 may be irregular and non-linearin order to avoid, slip past, bounce off of, deflect, and prevent traumaor other damage to various tissue structures encountered by the roundedtip.

With reference now to FIG. 14, there are shown medication pellets 104delivered subcutaneously in the delivery area 1308 through the incisionsite 1302 on the skin and dermis of a patient from a cannula 200inserted along the illustrative insertion path 1304. The swerving,curving, and weaving insertion path 1304 allows an assembled minimallytraumatic trocar to slip past various connective and fatty tissuescausing only micro-trauma and creating a linear space for the cannula200. The connective and fatty tissues can variously include nervetissue, blood vessels, arterioles, venuoles, capillaries, and lymphatictissue. Upon removal of the cannula 200 during medication pellet 104delivery, the connective and fatty tissues return toward their originalposition and pushing the delivered medication pellets 104 askew oroff-kilter and effectively locking the medication pellets 104 in placein the subcutaneous tissue. Therefore, even though the medicationpellets are extruded/delivered from the anterior opening of the cannula200 along a linear path corresponding to the length of the linearcannula, the medication pellets arrive at final delivery positionswithin the subcutaneous tissue in a non-linear path as a result of thenon-linear insertion path traversed by the assembled minimally traumatictrocar 1310 during insertion. The final delivery positions of themedication pellets may form a delivery pattern along a delivery paththat differs from the insertion path taken by the assembled atraumatictrocar. The delivery path runs from the delivery site, where theanterior rounded tip of the obturator reached upon full insertion andwhere a first medication pellet may be deposited, along a trail formedby the sequentially deposited medication pellets to the incision throughwhich the obturator entered the patient's tissue.

In an alternative embodiment, the non-linear swerving, curving, and/orweaving insertion path 1304 may displace various connective, fatty, andother tissues without causing trauma such that deposited medicationpellets are aligned in a linear or near linear pattern (i.e., depositionpath) due to the accumulated action and force of the displaced tissuesreturning toward their original position around the deposited medicationpellets.

Referring now to FIG. 15, there are shown medication pellets 104delivered through the incision site 1302 along a linear insertion path1304 a and an assembled minimally traumatic trocar 1320. Medicationpellets 104 may be spaced evenly, irregularly, or in groups (i.e., twomedication pellets close together, adjacent, or abutting, two othermedication pellets similarly close to one another but relatively furtherfrom the first two medication pellets, and so on). These groups may beof two or more pellets each. Although FIG. 15 shows medication pellets104 deposited in a nearly perfect linear orientation, the medicationpellets 104 may only be in approximately a linear orientation with oneor more of the medication pellets 104 being deposited slightly off ofthe linear centerline.

With reference to FIG. 16, there is shown an insertion area 1300 acontaining two sets of delivered medication pellets 104, wherein themedication pellets 104 are delivered along separate insertion paths 1304c and 1304 b. The separate insertion paths 1304 b and 1304 c areseparated by an angular distance 1321 corresponding to the angle 1322 cor 1322 b at which the centerline 1312 a and 1312 b of the assembledminimally traumatic trocar (not shown) was inserted into the incisionsite 1302 and from which it was removed. In the illustrative embodiment,the sum of angles 1321, 1322 c, and 1322 b is 180°. The angles 1322 cand 1322 b may be equal or not equal, and may range from a value of 0°through 180°. Thus, the separate insertion paths 1304 b and 1304 c forma fan arrangement, and in some embodiments multiple insertion paths maybe made between or outside of the insertion paths 1304 b and 1304 c.Although the medication pellets of insertion paths 1304 b and 1304 c areonly approximately linearly deposited, they may each be perfectly ornear perfectly linearly deposited. Further, the insertion paths 1304 band 1304 c are not limited to linear embodiments, and may includecurved, oscillating, and other non-linear paths.

Referring now to FIGS. 17A-C, there is shown a method of subcutaneousmedication delivery 1700 causing only minimal micro-trauma. Theminimally traumatic trocar used in this and the following steps of themethod 1700 may be formed from either the non-disposable cannula 200 andobturator 220 of FIGS. 2A-C, or the disposable cannula 600 and obturator500 of FIGS. 5 and 6. Where a disposable cannula 600 and obturator 500are employed, a preliminary step of opening an minimally traumatictrocar kit may be required. In one embodiment, the minimally traumatictrocar kit is disposable and contains a disposable obturator 500, adisposable cannula 600, and a punch scalpel 1000. In furtherembodiments, the minimally traumatic trocar kit also includes ahydrodissection microcannula 800, scissors, bandages, and antisepticointments, as well as instructions informing a user on how to assemblethe disposable trocar 700 and deliver pellets to a subcutaneous deliverysite.

The method begins in FIG. 17A at step 1701, where local anesthetic isadministered to numb the general delivery area or insertion area 1300.The local anesthetic may be topical or one or more injections.

The method 1700 continues at step 1702 by making an incision at aninsertion site 1302. The incision can be made with a scalpel or othercutting edge. In some embodiments, the incision is made by the punchscalpel 1000. In operation the punch scalpel base 1008 is placed on apatient's skin at an insertion site. The scalpel blade 1004 is thenpressed or plunged into the patient's skin to an incision depth. Theincision depth is limited by the punch scalpel bracket. In oneembodiment the scalpel blade is plunged into the patient's skin using ascalpel handle attached to the scalpel blade 1000. The incision width islimited to the width of the scalpel blade 1004. In another embodiment,the operator confirms that the scalpel blade 1004 is aligned with thedesired insertion site by positioning one or more guide notches 1012 atthe desired insertion site. In other embodiments, a preliminary step ofdiagramming the incision and delivery path(s) is performed, where amedical professional uses a temporary or indelible marking instrument(such as a felt tip pen) to identify both the incision site and theproposed insertion path(s) extending from the insertion site. Thesemarkings then operate as a guide for the medical profession duringperformance of the remaining steps of method 1700.

After making an incision at the insertion site 1302, at step 1704 ablunt tipped hydrodissection microcannula 800 is inserted into theincision, through the epidermis and dermis into the subcutaneous tissue.This insertion begins or creates the insertion path 1304, which theminimally traumatic trocar later follows. The hydrodissectionmicrocannula 800 may be inserted along a linear insertion path to aninsertion depth or length. In other embodiments, the hydrodissectionmicrocannula 800 may be inserted along a curved, side-to-side,oscillating, or otherwise non-linear insertion path to an insertiondepth or length. In all embodiments, the hydrodissection microcannula800 is inserted into the incision at an angle that is perpendicular ornon-parallel to the surface of the surrounding skin in order to passthrough a fascia layer, before being angled parallel to the surface ofthe surrounding skin and traveling along an insertion path. In oneembodiment, the hydrodissection microcannula 800 is inserted into theincision at an angle that is perpendicular or non-parallel to thesurface of the surrounding skin in order to pass through a superficialfat cell layer and a scarpa fascia tissue layer to enter a deep fattissue layer. In the illustrative embodiment, the hydrodissectionmicrocannula 800 is a 14-gauge stainless steel microcannula that is 15cm long.

At step 1706, during insertion of the hydrodissection microcannula 800into the incision and along the insertion path 1304, hydrodissectingfluid is injected along the insertion path 1304 into the tissuessurrounding the insertion path 1304. The hydrodissecting fluid maycomprise a 10 mL dose that is injected at one point of the insertionpath, periodically along the insertion path, or continuously along theinsertion path. Doses of hydrodissection fluid may range from 1 mL up to20 mL. Men and women may require different doses generally, i.e. 10 mLfor men and 5 mL for women. When the hydrodissecting fluid is injectedat only one point of the insertion path, it diffuses into thesurrounding subcutaneous tissue, superhydrating the tissue and creatinga short dissection plane so that the hydrodissection microcannula 800may more easily travel through the subcutaneous tissue with only minimalmicro-trauma. When the hydrodissecting fluid is injected periodically orcontinuously along the insertion path, the hydrodissecting fluidsuperhydrates tissues and creates a dissection plane along the entiretyof the insertion path. In all embodiments, the hydrodissection fluidatraumatically enlarges the space or cavity of the delivery site andlubricates the entry of the later assembled minimally traumatic trocar700 into the various tissues by gently hydrating, softening, anddisplacing those tissues from the insertion path. In this manner,hydrodissection facilitates easier, simpler, and less painful deliveryof the medication pellets. Hydrodissection is especially useful forfacilitating insertions into scarred and/or fibrotic tissues, such astissues that were the site of previous traumatic insertions, and/orrepeated insertions.

At decision diamond 1708, a determination is made as to whetheradditional doses of hydrodissection fluid are required. A medicalprofessional may determine to inject an additional dose ofhydrodissection fluid when the initial injection of hydrodissectionfluid fails to adequately ease insertion of the hydrodissectingmicrocannula 800 to a desired length or depth along the insertion path.Such a determination may be made when the initial insertion of thehydrodissection microcannula 800 encounters a blockage or firm tissuethat prevents minimally traumatic insertion. Additional doses ofhydrodissection fluid may cause the blockage or firm tissue tosuperhydrate and more easily shift out of the insertion path. In otherembodiments, an additional dose of hydrodissection fluid is deliveredalong a path parallel and adjacent to the first dose to provide a widerinsertion path for the later delivered pellets. Additional doses ofhydrodissection fluid may require removal of the hydrodissectionmicrocannula 800 or simply the removal of a syringe attached/coupled tothe hydrodissection microcannula 800 and replacement with a refilled orsecond syringe having the additional dose of hydrodissection fluid.

Upon injecting one or more doses of hydrodissection fluid, the methodcontinues at step 1710 where the hydrodissection microcannula 800 isremoved from the insertion path and incision. After removal of thehydrodissection microcannula 800, superhydrated subcutaneous tissuesurrounding a dissection plane and the insertion path remain.

At step 1712, a blunt edged cannula and round tipped obturator arecombined to form a minimally traumatic trocar. The minimally traumatictrocar used in this and the following steps of the method 1700 may beformed from either the non-disposable cannula 200 and obturator 220 ofFIGS. 2A-C, or the disposable cannula 600 and obturator 500 of FIGS. 5and 6. Where a disposable cannula 600 and obturator 500 are employed, apreliminary step of opening a minimally traumatic trocar kit may berequired. In one embodiment, the minimally traumatic trocar kit isdisposable and contains a disposable obturator 500, a disposable cannula600, and a punch scalpel 1000. In further embodiments, the minimallytraumatic trocar kit also includes a hydrodissection microcannula 800,scissors, bandages, and antiseptic ointments, as well as instructionsinforming a user on how to assemble the disposable trocar 700 anddeliver pellets to a subcutaneous delivery site.

In the illustrative disposable embodiment, the rounded tip 504 of theobturator 500 is inserted into the posterior cannula opening 608 andthrough the interior passage of the cannula 600, so that the rounded tip504 extends out through the anterior cannula opening 604. In a furtherembodiment, the obturator 500 is inserted into the posterior cannulaopening 608 so that the tab 508 on the obturator 500 interfaces with thenotch 612 of the cannula 600, and causes the assembled disposableminimally traumatic trocar to rotate about the central longitudinal axisas a single unit, i.e. rotating the obturator handle 510 causes thecannula 600 to rotate the same amount, and rotating the cannula handle616 causes the obturator 500 to rotate the same amount as well. In someembodiments, the medical professional performing the minimally traumatictrocar insertion waits between 1 minute and 10 minutes after completionof hydrodissection with the hydrodissecting microcannula 800 prior toinitiating step 1712 by inserting the assembled disposable minimallytraumatic trocar 700 into the incision and along the insertion path. Ina narrower embodiment, the medical professional performing the minimallytraumatic trocar insertion waits 5 minutes after completion ofhydrodissection with the hydrodissecting microcannula 800 prior toinitiating step 1712 by inserting the assembled disposable minimallytraumatic trocar 700 into the incision and along the insertion path. Inanother embodiment, the medical professional does not wait aftercompletion of the hydrodissection to initiate step 1712, but insteadproceeds directly to initiate step 1712.

At step 1714, the assembled minimally traumatic trocar 700 is insertedinto the incision site that is also termed an insertion site. Theanterior rounded tip 504 of the obturator 500 and thus, the assembledminimally traumatic trocar 700, enters the incision site, followed bythe remaining portions of the minimally traumatic trocar 700 asdescribed further below.

At step 1716, the incision site is probed with the assembled minimallytraumatic trocar 700 along an insertion path to a predeterminedinsertion length. The hydrodissection fluid delivered by thehydrodissection microcannula 800 effectively lubricated the insertionpath for passage of the assembled minimally traumatic obturator 700 bycreating a fluid buffer into which the assembled atraumatic obturator700 enters, and gently separating the various tissues that areencountered along the insertion path by the assembled minimallytraumatic trocar 700 during probing along the insertion path. Thislubricating effect softens and hydrates the tissues of the insertionpath, easing and improving the maneuverability of the minimallytraumatic trocar 700 within the tissue.

The insertion path may be linear or non-linear, and one or moreinsertion paths may originate at the same insertion site and be angledaway from one another in a fan-like orientation to allow the delivery ofmore medication pellets through a single incision. FIG. 15 demonstratesa linear insertion path 1304 a followed by the assembled minimallytraumatic trocar under the direction of a doctor or other medicalprofessional, FIG. 16 demonstrates angled insertion paths 1304 b and1304 c, and FIGS. 13 and 14 demonstrate an oscillating insertion path1304. An insertion path may only be angled with respect to anotherinsertion path passing through the same incision site 1302 as the firstinsertion path. An oscillating insertion path 1304 may be achieved bydirecting the posterior portion of the assembled minimally traumatictrocar 700 in a side-to-side fashion. The side-to-side, wiggle-waggle,weaving, and/or oscillating motion operates to pass the rounded tip 504around and past connective tissues in the subcutaneous tissue.

In operation, a doctor or assistant gently pushes the assembledminimally traumatic trocar 700 along an insertion path, moving theposterior portion of the assembled minimally traumatic trocar 700 to oneside or the other as the doctor or operator feels resistance fromconnective tissues and fatty tissues impeding the passage of theminimally traumatic trocar 700 along the insertion path. Thepredetermined length to which the insertion path is probed may bemeasured by observing the deformation or bulging of the outer dermislayer caused by the passage of the minimally traumatic trocar 700passing through the various subcutaneous tissues, i.e. fatty tissue,connective tissue, capillaries, venuoles, arterioles, nerves, etc. Inother embodiments, the predetermined length may be measured using thecannula markings 618. Using the cannula markings 618 ensures that theinsertion length is sufficient that all of the later loaded medicationpellets 104 can be deposited within the subcutaneous tissue or to ensurethat the medication pellets 104 are deposited a desired distance fromthe incision 1302.

At step 1718, the obturator 500 is removed from the cannula 600 and theincision. In one embodiment, the cannula 600 is kept in position, whilethe obturator 500 is removed. The cannula 600 may be kept in position byholding the cannula handle 616 while the obturator handle 510 is used toremove the obturator 500.

The method 1700 continues in FIG. 17B at step 1720, where a medicationpellet 104 is loaded into the interior passage of the cannula 600through the medication slot 614. In one embodiment, the loadedmedication pellet is pushed toward the anterior opening 604 at theanterior end of the cannula 600 with the obturator 500, but not throughthe anterior opening 604. In another embodiment, the loaded medicationpellet is pushed toward the anterior opening 604 at the anterior end ofthe cannula 600 and through the anterior opening 604.

At decision diamond 1722, a next medication pellet may be loaded intothe interior passage of the cannula 600 in the same fashion as the firstmedication. The next medication pellet 104 can be a second, third,fourth, fifth, sixth, etc. medication pellet depending on the number ofpreviously loaded medication pellets. In one embodiment, when a nextpellet is loaded into the interior passage of the cannula 600, the mostrecently loaded medication pellet is pushed toward the anterior opening604 at the anterior end of the cannula 600 with the disposable obturator500. Any next or subsequently loaded medication pellets are pushedthrough the cannula 600 so that none of the previously loaded medicationpellets 104 are extruded through the anterior opening 604 at theanterior end of the cannula 600 and delivered to a delivery area 1308.

At step 1724, the desired number of medication pellets 104 have beenloaded into the interior passage of the cannula 600, and the blunt tip604 of the obturator 500 is inserted into the posterior opening 608 ofthe cannula 600. The blunt rounded tip 604 of the obturator 500 ispassed through the interior passage of the cannula 600 to abut the mostposterior loaded medication pellet 104 and push all pellets into adesired position. In one embodiment, the desired position for themedication pellets is for them to be loaded so that the pellets 104press against and abut one another and align with the cannula markings618, as well as the anterior opening 604 of the cannula 600.

At step 1726, the loaded medication pellet(s) 104 are extruded throughthe anterior opening 604 of the cannula 600 and delivered to asubcutaneous delivery area 1308. In one embodiment, the cannula 600 isslowly removed from the incision 1302 as the disposable obturator 500 isinserted further into the interior passage of the cannula 600. By slowlyremoving the cannula 600 during insertion of the obturator 500, thedelivery site 1306 for each successive medication pellet is shiftedcloser to the incision 1302. Moving the delivery site 1306 of successivepellets allows the medication pellets to be delivered in a linearformation as in FIG. 15, or a snaking, winding or “staggered” formationas in FIGS. 13 and 14, as opposed to the radial clump 130 of the priorart in FIG. 1D. Thus, simultaneous removal of the cannula 600 andinsertion or depression of the obturator 500 forces successivemedication pellets out of the cannula 600 into a delivery site that isunique for each medication pellet. In some embodiments, completeextrusion of the medication pellets results in full insertion of theobturator 500 into the interior passage of the cannula 600, such thatthe obturator 500 and cannula 600 are again assembled into the minimallytraumatic trocar 700.

At step 1728, the obturator 500 and cannula 600, which may be assembledas the disposable minimally traumatic trocar 700, are retracted alongthe insertion path toward the incision 1302. In one embodiment, at leastone of the anterior rounded tip 504, an anterior portion of the cannula600, or any combination thereof remains within the incision 1302, whilemost of the length of the tubular obturator body 502 and the tubularcannula body 602 are removed from the incision 1302. Notably, whetherthe minimally traumatic disposable trocar 700 was inserted along alinear path as in FIGS. 15 and 16, or a snaking path as in FIGS. 13 and14, the corresponding minimally traumatic trocar 700 is removeddirectly, i.e. without any snaking, wiggling, or wagging, such that theremoval of the minimally traumatic trocar 700 follows a linear orapproximately linear path. In other words, no matter the type ofinsertion path, the minimally traumatic trocar 700 is retracted with alinear motion along a linear path. As described above, when theinsertion path is non-linear, displaced tissue resumes its approximateoriginal location and locks one or more delivered medication pellets inplace in the subcutaneous tissue. When the insertion path is linear,tissue may still contract about the delivered medication pellet(s) tohold them in place, although the force of this holding action may beless than when a non-linear insertion path is used.

At step 1730, the disposable obturator 500 is removed from the cannula600. At decision diamond 1732, a doctor or assistant may determinewhether to proceed with a second or next insertion or whether to beginterminating the method. If termination is elected, the method proceedsto step 1734 in FIG. 17C where the cannula 500 or assembled atraumatictrocar 700 is removed from the incision 1302 or the insertion site; theincision 1302 is closed and the method ends. If a second or nextinsertion is elected, the method proceeds to step 1736.

At step 1736, the blunt tipped hydrodissection microcannula 800 is onceagain inserted into the incision, through the epidermis and dermis intothe subcutaneous tissue. This insertion begins or creates a secondinsertion path, which the atraumatic trocar later follows. As describedabove with reference to FIG. 16, the second insertion path begins at thesame insertion point as the first insertion path, but extends at anangle to the first insertion path, so that the delivered medicationpellets from the first insertion are not immediately adjacent to thepellets that are delivered along the second insertion path. Achievingthis requirement that the first and second paths are not immediatelyadjacent may require an angular separation between the first and secondpaths of >5°, such as 5°-20°, 20°-40°, 40°-100°, or 100°-180°. Thesecond insertion path along which the hydrodissection microcannula 800is inserted may be linear and extend to a second insertion depth orlength. In other embodiments, the second insertion path of thehydrodissection microcannula 800 may be curved, oscillating, non-linear,or result from an operator moving the posterior end of the atraumatictrocar (and thus the anterior end as well, though in the oppositedirection) side-to-side during insertion. In the illustrativeembodiment, the hydrodissection microcannula 800 used for the creationof the second insertion path is a 14-gauge stainless steel microcannulathat is 15 cm long.

During insertion of the hydrodissection microcannula 800 along thesecond insertion path at step 1736, hydroddissecting fluid is injectedalong the second insertion path at step 1738. The hydrodissectin fluidis injected into the tissues surrounding the second insertion path. Aswith hydrodissection of the first insertion path, the hydrodissectingfluid may comprise a 10 mL dose injected at one point of the secondinsertion path, periodically along the second insertion path, orcontinuously along the second insertion path. The dose ofhydrodissecting fluid for the second insertion path continues to rangefrom 1 mL up to 20 mL. As with hydrodissection of the first insertionpath, the hydrodissecting fluid diffuses into the subcutaneous tissuesurrounding the second insertion path, superhydrating that tissue andcreating a dissection plane along the second insertion path by enlargingthe cavity space created by the passage of the hydrodissectionmicrocannula 800 with only minimal micro-trauma. In some embodiments,the second insertion path lies in the same dissection plane as the firstinsertion path, such that the first dissection plane and the seconddissection plane are the same dissection plane.

Upon injection of one dose of hydrodissecting fluid along the secondinsertion path, a determination is made at decision diamond 1740 as towhether additional dose(s) of hydrodissection fluid are required. If theoperator (or medical professional) determines to inject another dose ofhydrodissection fluid, the method reverts back to step 1736 and proceedsas described above.

When a medical professional performing this method has injected one ormore doses of hydrodissection fluid and determined that no furtheradministration of hydrodissection fluid are required, the methodcontinues at step 1742 where the hydrodissection microcannula 800 isremoved from the second insertion path and incision. After removal ofthe hydrodissection microcannula 800, superhydrated subcutaneous tissuesurrounding a second dissection plane and the second insertion pathremain.

The method 1700 continues in FIG. 17C at step 1744, where the cannula600 and the obturator 500 are again combined to form the minimallytraumatic trocar 700. In some embodiments, the same cannula 600 andobturator 500 that were used in steps 1712-1730 is used in step 1744 andthe ensuing method steps. In other embodiments, the cannula 600 andobturator 500 that were used in steps 1712-1730 are set aside (disposedof or disinfected) and a new cannula 600 and obturator 500 are retrievedto continue the method 1700. Since the atraumatic trocar 700 is removedfrom the incision to more readily enable entry of the hydrodissectionmicrocannula 800, an assembled atraumatic trocar 700 must be insertedagain into the incision as an assembled unit. Where the cannula 600 andobturator 500 used in steps 1712-1730 are again used, no assembly may berequired as the cannula 600 and obturator 500 were removed from theincision as the assembled atraumatic trocar and may remain so until itsuse at step 1744. Thus, the anterior rounded tip 604 of the obturatorfirst penetrates the dermis and epidermis upon reinsertion, beforeentering into the subcutaneous tissue within the incision 1302 orinsertion site. In a further embodiment, the assembly occurs byinserting the obturator 500 into the posterior cannula opening 608 sothat the tab 508 on the obturator 600 interfaces with the notch 612 onthe tubular cannula body 602.

In some embodiments, the medical professional performing the minimallytraumatic trocar insertion waits between 1 and 10 minutes aftercompletion of hydrodissection with the hydrodissecting microcannula 800prior to initiating step 1744 by inserting the assembled disposableminimally traumatic trocar 700 into the incision and along the insertionpath. In a narrower embodiment, the medical professional performing theminimally traumatic trocar insertion waits 5 minutes after completion ofhydrodissection with the hydrodissecting microcannula 800 prior toinitiating step 1744 by inserting the assembled disposable minimallytraumatic trocar 700 into the incision and along the insertion path. Inanother embodiment, the medical professional does not wait aftercompletion of the hydrodissection to initiate step 1744, but insteadproceeds directly to initiate step 1744.

At step 1746, the assembled trocar 700 is angled away from the previousinsertion path and along the second insertion path established by thehydrodissection microcannula 800 in steps 1736-1742, as with theinsertion paths 1304 b and 1304 c in FIG. 16. The assembled trocar 700is then used to probe along the length of the next or second insertionpath to a predetermined insertion length. This predetermined insertionlength may be dependent on the number of medication pellets to bedelivered, i.e. a longer insertion length may be desired when moremedication pellets are to be delivered. However, it should be noted thateven just a single medication pellet may be inserted along an insertionpath that is the same length as the insertion path for several pellets.As with the initial insertion path, the second insertion path can belinear or oscillating.

At step 1748, as with step 1718, the obturator 500 is removed from thecannula 600 and the incision 1302, while keeping the cannula 600 inplace within the incision 1302 or insertion point.

At step 1750, as with step 1720, a medication pellet 104 is loaded intothe interior passage of the cannula 600 through the medication slot 614.In one embodiment, only one medication pellet is loaded into themedication slot.

At decision diamond 1752, as with decision diamond 1722, a nextmedication pellet may be loaded into the interior passage of the cannula600 in the same fashion as the first medication pellet, or the methodmay proceed to step 1754 when the desired number of medication pelletshave been loaded into the interior passage of the cannula 600.

At step 1754, as with step 1724, the desired number of medicationpellets 104 have been loaded into the interior passage of the cannula600, and the anterior blunt tip 504 of the obturator 500 is insertedinto the posterior opening 608 of the cannula 600. The anterior roundedtip 504 of the obturator 500 is passed through the interior passage ofthe cannula 600 to abut the most posterior loaded medication pellet 104and push all pellets into a desired position within the cannula 600.

At step 1756, as with step 1726, the loaded medication pellet(s) 104 areextruded through the anterior opening 604 of the cannula 600 anddelivered to a second subcutaneous delivery site within the generaldelivery area. The delivery area may include both the first deliverysite and the second delivery site.

At step 1758, as with step 1728, the assembled minimally traumatictrocar 700 is retracted along the second insertion path toward theincision 1302. In one embodiment, at least an anterior portion of thecannula 600 remains within the incision 1302, allowing the method toeither terminate at step 1734 or return to decision diamond 1732 andcontinue with the establishment of a third or next insertion path forreception of a third set of medication pellet(s).

At step 1734, the cannula 600 or assembled minimally traumatic trocar700 is removed from the incision 1302, the incision 1302 is closed andthe method 1700 ends. The incision 1302 may be closed with stitches,medical glue, butterfly bandage, or similar bandaging means.

Referring now to FIGS. 18A-B, there is shown another method ofsubcutaneous medication delivery 1800 causing only minimal micro-trauma.The method 1800 begins in FIG. 18A at step 1801, where local anestheticis administered to numb the general delivery area or insertion area1300. The local anesthetic may be topical or one or more injections.

The method 1800 continues at step 1802 by making an incision at aninsertion site 1302. This incision 1302 can be made with a scalpel orother cutting edge. In some embodiments, the incision 1302 is made bythe punch scalpel 1000. In other embodiments, a preliminary step ofdiagramming the incision and delivery path(s) is performed, where amedical professional uses a temporary or indelible marking instrument(such as a felt tip pen) to identify both the incision site and theproposed insertion path(s) extending from the insertion site. Thesemarkings then operate as a guide for the medical profession duringperformance of the remaining steps of method 1800.

At step 1804, a blunt edged cannula and round tipped obturator arecombined to form a minimally traumatic trocar. The minimally traumatictrocar used in this and the following steps of the method 1800 may beformed from the disposable cannula and obturator disclosed in FIGS. 5Aand 5C of the cross-referenced non-provisional patent application Ser.No. 16/997,803. In the illustrative embodiment described herein, theminimally traumatic trocar used in this and the following steps of themethod 1800 may be the non-disposable trocar 240 formed from thenon-disposable cannula 200 and obturator 220 of FIGS. 2A-C. In theillustrative non-disposable embodiment, the rounded tip 224 of theobturator 220 is inserted into the posterior cannula opening 206 andthrough the interior passage of the cannula 200, so that the rounded tip224 extends out through the anterior cannula opening 204. In a furtherembodiment, the obturator 220 is inserted into the posterior cannulaopening 206 so that the tab 232 on the obturator 220 interfaces with thenotch 212 on the tubular cannula body 202, and causes the assembledminimally traumatic trocar 240 to rotate about the centerline 1312 ofthe minimally traumatic trocar as a single unit, i.e. rotating theobturator handle 230 causes the cannula 200 to rotate the same amount,and rotating the cannula handle 210 causes the obturator 220 to rotatethe same amount as well.

At step 1806, the assembled minimally traumatic trocar 240 is insertedinto the incision site 1302. The anterior rounded tip 224 of theobturator 220 and thus, the assembled minimally traumatic trocar 240,enters the incision 1302, followed by the remaining portions of theminimally traumatic trocar 240 as described further below.

At step 1808, the incision 1302 is probed with the assembled minimallytraumatic trocar 240 along an insertion path to a predeterminedinsertion length. The insertion path may be linear or non-linear, andone or more insertion paths may originate at the same insertion/incisionsite and be angled away from one another in a fan-like orientation toallow the delivery of more medication pellets through a single incision.FIG. 15 demonstrates a linear insertion path 1304 a followed by theassembled minimally traumatic trocar 240 under the direction of a doctoror other medical professional, FIG. 16 demonstrates angled insertionpaths 1304 b and 1304 c, and FIGS. 13 and 14 demonstrate an oscillatinginsertion path 1304. An insertion path may only be angled with respectto another insertion path passing through the same incision 1302 as thefirst insertion path. An oscillating insertion path 1304 may be achievedby directing the posterior portion of the assembled minimally traumatictrocar 240 in a side-to-side fashion. The side-to-side, wiggle-waggle,weaving, and/or oscillating motion operates to pass the rounded tip 224around and past connective tissues in the subcutaneous tissue.

In operation, a doctor or medical professional gently pushes theassembled minimally traumatic trocar 240 along an insertion path, movingthe posterior portion of the assembled minimally traumatic trocar 240 toone side or the other as the operator feels resistance from connectivetissues and fatty tissues impeding the passage of the minimallytraumatic trocar 240 along the insertion path. The predetermined lengthto which the insertion path is probed may be measured by observing thedeformation or bulging of the outer dermis layer caused by the passageof the minimally traumatic trocar 240 passing through the varioussubcutaneous tissues, i.e. fatty tissue, connective tissue, capillaries,venuoles, arterioles, nerves, etc. In other embodiments, thepredetermined length may be measured using the cannula markings 214.Using the cannula markings 214 ensures that the insertion length issufficient that all of the later loaded medication pellets 104 can bedeposited within the subcutaneous tissue or to ensure that themedication pellets 104 are deposited a desired distance from theincision 1302 or insertion site.

At step 1810, the assembled trocar 240 delivers a particular agent(i.e., a numbing solution, anesthetic, and/or hydrodissection fluid) tothe tissue along the insertion path through openings 228 in theobturator 220 during the probing of step 1808. One of these openings 228may be located at or comprise the most anterior portion of the anteriorblunt tip 224 of the obturator 220, so that the delivered agent is thefirst element of the assembled minimally traumatic trocar 240 to contacttissues along the insertion path. Alternatively, or in addition to thisconfiguration, the obturator 220 may include one or more openingsproximal to the anterior rounded tip (as shown in FIGS. 2B and 3A-E)that deliver the agent to tissues adjacent to the anterior rounded tip224 and the tubular body 222 of the obturator 220 and tubular cannulabody 202. The delivered agent effectively lubricates the passage of theassembled minimally traumatic trocar 240 by creating a fluid bufferaround the assembled minimally traumatic trocar 240 and gentlyseparating the various tissues encountered by the assembled minimallytraumatic trocar 240 during probing along an insertion path. Thislubricating effect softens and hydrates tissues encountered, easing andimproving the maneuverability of the minimally traumatic trocar withinthe tissue.

Where the delivered agent is hydrodissecting fluid, the hydrodissectingfluid may comprise a 10 mL dose that is injected at one point of theinsertion path, periodically along the insertion path, or continuouslyalong the insertion path. Doses of hydrodissection fluid may range from1 mL up to 20 mL. When the hydrodissecting fluid is injected at only onepoint of the insertion path, it diffuses into the surroundingsubcutaneous tissue, superhydrating the tissue and creating a shortdissection plane so that the assembled atraumatic trocar 240 may moreeasily travel through the subcutaneous tissue with minimal amounts ofmicro-trauma. When the hydrodissecting fluid is injected periodically orcontinuously along the insertion path, the hydrodissecting fluidsuperhydrates tissues and creates a dissection plane along the entiretyof the insertion path. In all embodiments, the hydrodissection fluidenlarges the space or cavity of the delivery site and lubricates theentry of the assembled atraumatic trocar 240 into the various tissueswith minimal micro-trauma by gently hydrating, softening, and displacingthose tissues from the insertion path. In this manner, hydrodissectionfacilitates easier, simpler, and less painful delivery of the medicationpellets.

In these embodiments, the particular agent (i.e., one or more numbingsolutions, such as anesthetics and/or hydrodissection fluids) may bedelivered through only two openings proximate to the anterior roundedtip 224 of the obturator 220, or through openings that spiral along thelength of the portion of the obturator tubular body 222 that extendsbeyond the anterior opening of the cannula 204. The inventorhypothesizes that the various agents create a fluid channel about theassembled minimally traumatic trocar 240, and thereby enlarges the spaceor cavity of the delivery site with minimal amounts of micro-trauma andfacilitates delivery of the medication pellets. The inventor furtherhypothesizes that hydrodissection facilitates insertion into scarredand/or fibrotic tissues, such as tissues that were the site of previoustraumatic insertions, and/or repeated insertions.

At decision diamond 1812, a determination is made as to whetheradditional doses of the particular agent or hydrodissection fluid arerequired. A medical professional may determine to inject an additionaldose, such as of hydrodissection fluid, when the initial administrationof hydrodissection fluid fails to adequately ease insertion of theminimally traumatic trocar 240 to a desired length or depth along theinsertion path. Such a determination may be made when the initialinsertion of the minimally traumatic trocar 240 encounters a blockage orfirm tissue that prevents minimally traumatic insertion. A blockagepreventing minimally traumatic insertion of the trocar 240 would requirethe surrounding and/or blocking tissue to tear, rupture, and/or inflamefor the minimally traumatic trocar 240 to pass through the tissue.Additional doses of hydrodissection fluid may cause the blockage or firmtissue to superhydrate and more easily shift out of the insertion path.Additional doses of hydrodissection fluid may be administered through asyringe removably coupled to the threaded posterior end 234 of theobturator 220. In practice, a medical professional may inject a furtherdose of hydrodissection fluid through the minimally traumatic trocar 240into the blocking tissue and/or surrounding tissue with the same syringeused to inject the first dose of hydrodissection fluid into the tissuesof the insertion path. This further dose may be 10 mL of hydrodissectionfluid that remain in the syringe after an initial dose of 10 mL ofhydrodissection fluid, i.e. the syringe originally held 20 mL. In otherembodiments, the syringe may be decoupled from the minimally traumatictrocar 240 in order to retrieve another 10 mL dose of hydrodissectionfluid. Additional doses of hydrodissection fluid administered throughthe minimally traumatic trocar 240 may be dispensed from the obturatoropenings 228 into the tissues at or surrounding one point of theinsertion path, several points along the insertion path, and/orcontinuously along the insertion path.

Upon injecting one or more doses of hydrodissection fluid, the methodcontinues at step 1814, the obturator 220 is removed from the cannula200 and the incision 1302. In one embodiment, the cannula 200 is kept inposition, while the obturator 220 is removed. The cannula 200 may bekept in position by holding the cannula handle 210 while the obturatorhandle is used to remove the obturator 220.

At step 1816, a medication pellet 104 is loaded into the interiorpassage of the cannula 200 through the medication slot 208. In oneembodiment, the loaded medication pellet is pushed toward the anterioropening 204 at the anterior end of the cannula 200 with the obturator220, but not through the anterior opening 204. In another embodiment,the loaded medication pellet is pushed toward the anterior opening 204at the anterior end of the cannula 200 and through the anterior opening204 into the subcutaneous tissue surrounding the delivery site 1306,and/or along the insertion path 1304 (i.e. the delivery area 1308).

At decision diamond 1818, a next medication pellet may be loaded intothe interior passage of the cannula 200 in the same fashion as the firstmedication. The next medication pellet 104 can be a second, third,fourth, fifth, sixth, etc. medication pellet depending on the number ofpreviously loaded medication pellets. In one embodiment, when a nextpellet is loaded into the interior passage of the cannula 200, the mostrecently loaded medication pellet is pushed toward the anterior opening204 at the anterior end of the cannula 200 with the obturator 220. Anynext or subsequently loaded medication pellets are pushed through thecannula 200 so that none of the previously loaded medication pellets areextruded through the anterior opening 204 at the anterior end of thecannula 200 and delivered to a delivery area 1308.

At step 1820, the desired number of medication pellets 104 have beenloaded into the interior passage of the cannula 200, and the anteriorblunt tip 224 of the obturator 220 is inserted into the posterioropening 206 of the cannula 200. The blunt tip 224 of the obturator 220is passed through the interior passage of the cannula 200 to abut themost posterior loaded medication pellet 104 and push all pellets into adesired position. In one embodiment, the desired position for themedication pellets is as depicted in FIG. 12B, where the loaded pellets104 pressed to abut one another and align with the cannula markings 214,as well as the anterior opening 204 of the cannula 200.

At step 1822, the loaded medication pellet(s) 104 are extruded throughthe anterior opening 204 of the cannula 200 and delivered to asubcutaneous delivery area 1308. In one embodiment, the cannula 200 isslowly removed from the incision 1302 as the obturator 220 is insertedfurther into the interior passage of the cannula 200. By slowly removingthe cannula 200 during insertion of the obturator 220, the delivery site1306 for each successive medication pellet is shifted closer to theincision 1302. Moving the delivery site 1306 of successive pelletsallows the medication pellets to be delivered in a linear formation asin FIGS. 15 and 16, or a snaking, winding or “staggered” formation as inFIGS. 13 and 14, as opposed to the radial clump 130 of the prior art inFIG. 1D. Thus, simultaneous removal of the cannula 200 and insertion ordepression of the obturator 220 forces successive medication pellets outof the cannula 200 into a delivery site that is unique for eachmedication pellet. In some embodiments, complete extrusion of themedication pellets results in full insertion of the obturator 220 intothe interior passage of the cannula 200, such that the obturator 220 andcannula 200 are again assembled into the minimally traumatic trocar 240.

At step 1824, the obturator 220 and cannula 200, which may be assembledas the minimally traumatic trocar 240, are retracted along the insertionpath toward the incision 1302. In one embodiment, at least one of theanterior rounded tip 224, an anterior portion of the cannula 200, or anycombination thereof remains within the incision 1302 while most of thelength of the tubular obturator body 222 and the tubular cannula body202 are removed from the incision 1302. Notably, whether the minimallytraumatic trocar 240 was inserted along a linear path as in FIGS. 15 and16, or a snaking path as in FIGS. 13 and 14, the corresponding minimallytraumatic trocar 240 is removed directly, i.e. without any snaking,wiggling, or wagging, such that the removal of the minimally traumatictrocar 240 follows a linear or approximately linear path. In otherwords, no matter the type of insertion path, the minimally traumatictrocar 240 is retracted with a linear motion along a linear path. Asdescribed above, when the insertion path is non-linear, displaced tissueresumes its approximate original location and locks one or moredelivered medication pellets in place in the subcutaneous tissue. Whenthe insertion path is linear, tissue may still contract about thedelivered medication pellet(s) to hold them in place, although the forceof this holding action may be less than when a non-linear insertion pathis used.

At decision diamond 1826, a doctor or other medical professional maydetermine whether to proceed with a second or next insertion or whetherto begin terminating the method. If termination is elected, the methodproceeds to step 1828 where the cannula 200 or assembled minimallytraumatic trocar 240 is entirely removed from the incision 1302 site;and the incision 1302 is closed such that the method ends. If a secondor next insertion is elected, the method proceeds to step 1830.

At step 1830, an assembled trocar 240 is angled away from the previousinsertion path, as with the insertion paths 1304 b and 1304 c in FIG.16, towards a next or second insertion path. The second insertion pathbegins at the same insertion point as the first insertion path, butextends at an angle to the first insertion path, so that the deliveredmedication pellets from the first insertion are not immediately adjacentto the pellets that are delivered along the second insertion path.Achieving this requirement that the first and second paths are notimmediately adjacent may require an angular separation between the firstand second paths of >5°, such as 5°-20°, 20°-40°, 40°-100°, or100°-180°. The assembled trocar 240 is then used to probe along thelength of the next or second insertion path to a predetermined insertionlength. This predetermined insertion length may be dependent on thenumber of medication pellets to be delivered, i.e. a longer insertionlength may be desired when more medication pellets are to be delivered.However, it should be noted that even just a single medication pelletmay be inserted along an insertion path that is same length as theinsertion path for several pellets. As with the initial insertion path,the second insertion path can be linear or oscillating, but must beangle away from the initial insertion path.

Step 1830 may additionally require the assembly of another minimallytraumatic trocar if the minimally traumatic trocar used for the initialinsertion of medication pellets is not used for the subsequentinsertion. In an alternative embodiment, step 1830 may require there-assembly of the minimally traumatic trocar 240 used in the initialinsertion of medication pellets if the obturator 220 was not fullyinserted into the interior passage of the cannula 200 during retractionalong the insertion path in step 1824. Where re-assembly of theobturator 220 and cannula 200 is necessary, the operator may need toperform the re-assembly ex vivo and re-insert the re-assembled minimallytraumatic trocar 240 into the incision 1302. Alternatively, re-assemblymay occur while at least one of the anterior rounded tip 224, ananterior portion of the cannula 200, or any combination thereof remainswithin the incision 1302, which does not require re-insertion of theassembled minimally traumatic trocar 240 into the incision 1302 (as aportion of it remained within the incision).

At step 1832, the assembled trocar 240 delivers a particular agent(i.e., a numbing solution, anesthetic, and/or hydrodissection fluid) tothe tissue along the second or subsequent insertion path throughopenings 228 in the obturator 220 during the probing of step 1830. Oneof these openings 228 may be located at or comprise the most anteriorportion of the anterior blunt tip 224 of the obturator 220, so that thedelivered agent is the first element of the assembled minimallytraumatic trocar 240 to contact tissues along the second insertion path.Alternatively, or in addition to this configuration, the obturator 220may include one or more openings proximal to the anterior rounded tip(as shown in FIGS. 2B and 3A-E) that deliver the agent to tissuesadjacent to the anterior rounded tip 224 and the tubular body 222 of theobturator 220 and tubular cannula body 202. The delivered agenteffectively lubricates the passage of the assembled minimally traumatictrocar 240 by creating a fluid buffer around the assembled minimallytraumatic trocar 240 and gently separating the various tissuesencountered by the assembled minimally traumatic trocar 240 duringprobing along the second insertion path.

At decision diamond 1834, a determination is made as to whetheradditional doses of the particular agent or hydrodissection fluid arerequired. A medical professional may determine to inject an additionaldose, such as of hydrodissection fluid, when the initial administrationof hydrodissection fluid fails to adequately ease insertion of theminimally traumatic trocar 240 to a desired length or depth along thesecond insertion path. In practice, an medical professional may inject afurther dose of hydrodissection fluid through the atraumatic trocar 240into the blocking tissue and/or surrounding tissue with the same syringeused to inject the first dose of hydrodissection fluid into the tissuesof the second insertion path.

Upon injecting one or more doses of hydrodissection fluid, the method1800 continues at step 1836, where the obturator 220 is removed from thecannula 200 and the incision 1302. In one embodiment, the cannula 200 iskept in position, while the obturator 220 is removed. The cannula 200may be kept in position by holding the cannula handle 210 while theobturator handle is used to withdraw the obturator 220.

At step 1838, a medication pellet 104 is loaded into the interiorpassage of the cannula 200 through the medication slot 208. In oneembodiment, the loaded medication pellet is pushed toward the anterioropening 204 at the anterior end of the cannula 200 with the obturator220, but not through the anterior opening 204. In another embodiment,the loaded medication pellet is pushed toward the anterior opening 204at the anterior end of the cannula 200 and through the anterior opening204 into the subcutaneous tissue surrounding the second delivery site,and/or along the second insertion path (i.e. the second delivery area).

At decision diamond 1840, a next medication pellet may be loaded intothe interior passage of the cannula 200 in the same fashion as the firstmedication. The next medication pellet 104 can be a second, third,fourth, fifth, sixth, etc. medication pellet depending on the number ofpreviously loaded medication pellets. In one embodiment, when a nextpellet is loaded into the interior passage of the cannula 200, the mostrecently loaded medication pellet is pushed toward the anterior opening204 at the anterior end of the cannula 200 with the obturator 220. Anynext or subsequently loaded medication pellets are pushed through thecannula 200 so that none of the previously loaded medication pellets areextruded through the anterior opening 204 at the anterior end of thecannula 200 and delivered to the second delivery area.

At step 1842, the desired number of medication pellets 104 have beenloaded into the interior passage of the cannula 200, and the anteriorblunt tip 224 of the obturator 220 is inserted into the posterioropening 206 of the cannula 200. The blunt tip 224 of the obturator 220is passed through the interior passage of the cannula 200 to abut themost posterior loaded medication pellet 104 and push all pellets into adesired position. In one embodiment, the desired position for themedication pellets is as depicted in FIG. 12B, where the loaded pellets104 pressed to abut one another and align with the cannula markings 214,as well as the anterior opening 204 of the cannula 200.

At step 1844, the loaded medication pellet(s) 104 are extruded throughthe anterior opening 204 of the cannula 200 and delivered to a secondsubcutaneous delivery area. In one embodiment, the cannula 200 is slowlyremoved from the incision 1302 as the obturator 220 is inserted furtherinto the interior passage of the cannula 200. By slowly removing thecannula 200 during insertion of the obturator 220, the delivery site foreach successive medication pellet is shifted closer to the incision1302. Moving the delivery site 1306 of successive pellets allows themedication pellets to be delivered in a linear formation as in FIGS. 15and 16, or a snaking, winding or “staggered” formation as in FIGS. 13and 14, as opposed to the radial clump 130 of the prior art in FIG. 1D.Thus, simultaneous removal of the cannula 200 and insertion ordepression of the obturator 220 forces successive medication pellets outof the cannula 200 into a delivery site that is unique for eachmedication pellet. In some embodiments, complete extrusion of themedication pellets results in full insertion of the obturator 220 intothe interior passage of the cannula 200, such that the obturator 220 andcannula 200 are again assembled into the minimally traumatic trocar 240.

At step 1846, the obturator 220 and cannula 200, which may be assembledas the minimally traumatic trocar 240, are retracted along the insertionpath toward the incision 1302. In one embodiment, at least one of theanterior rounded tip 224, an anterior portion of the cannula 200, or anycombination thereof remains within the incision 1302 while most of thelength of the tubular obturator body 222 and the tubular cannula body202 are removed from the incision 1302. Leaving at least one of theanterior rounded tip 224, an anterior portion of the cannula 200, or anycombination thereof remains within the incision 1302 allows the method1800 to either terminate at the ensuing step 1828, or return to decisiondiamond 1826 and continue with the establishment of a third or nextinsertion path for reception of a third set of medication pellet(s).

Notably, whether the minimally traumatic trocar 240 was inserted along alinear path as in FIGS. 15 and 16, or a snaking path as in FIGS. 13 and14, the corresponding minimally traumatic trocar 240 is removeddirectly, i.e. without any snaking, wiggling, or wagging, such that theremoval of the minimally traumatic trocar 240 follows a linear orapproximately linear path. Thus, no matter the type of insertion path,the minimally traumatic trocar 240 is retracted with a linear motionalong a linear path. As described above, when the insertion path isnon-linear, displaced tissue resumes its approximate original locationand locks one or more delivered medication pellets in place in thesubcutaneous tissue. When the insertion path is linear, tissue may stillcontract about the delivered medication pellet(s) to hold them in place,although the force of this holding action may be less than when anon-linear insertion path is used.

At step 1828, the cannula 200 or assembled minimally traumatic trocar240 is removed from the incision 1302, the incision 1302 is closed andthe method 1800 ends. The incision 1302 may be closed with stitches,medical glue, butterfly bandage, or similar bandaging means.

In further embodiments, the pellet dosage of a target compound, i.e.testosterone, estrogen, progesterone, is determined in relation to abaseline measurement of the target compound in the patient's bloodstream. The baseline measurement is determined prior to delivery ofmedication pellets with minimal amounts of micro-trauma. The efficacy ofthe selected dosage is then determined by measuring the amount of thecompound per volume, termed a compound level, in the patient'sbloodstream at various time periods after subcutaneous insertion of themedication pellets. In various embodiments, the compound level ismeasured one week, one month, three months, and six months after pelletdelivery with minimal amounts of micro-trauma. In other embodiments, thecompound level is measured weekly, biweekly, or monthly. Later minimallytraumatic pellet delivery doses are then adjusted, i.e. increased ordecreased, depending on whether the compound levels resulting from aprevious minimally traumatic delivery were higher or lower than desired.

In an exemplary embodiment, normal testosterone blood levels range from400 to 1,200 nanograms/deciliter (ng/dl), but a patient's testosteronebaseline level is measured at 50 ng/dl. One week after atraumaticallydelivering one 200 mg pellet of testosterone, the patient's testosteronelevel is measured at 60 ng/dl, one month after atraumatic delivery thepatient's testosterone level is measured at 100 ng/dl, and three monthsafter atraumatic delivery the patient's testosterone level is measuredat 105 ng/dl. This feedback may suggest to a doctor or operator that asubsequent atraumatically delivered pellet dosage should be increase totwo, three, four, or more 200 mg pellets. This method of baselinemeasurement, followed by post-delivery measurement accounts for thedifferences in patient body composition, activity level, and metabolism,which vary significantly and affect pellet dissolution into the bloodstream.

The atraumatic trocar apparatus, system and method described above maybe used to deliver medication pellets into subcutaneous tissue withlittle, minimal, or only micro-traumatic damage to the subcutaneoustissue. The inventor hypothesizes that the atraumatic insertion andsubcutaneous delivery of medication pellets improves the absorption rateof the medication pellets over prior art trocar apparatuses by limitingor eliminating trauma, such as laceration to nerves, arterioles,venuoles, capillaries, or fat cell membrane punctures, which result incellular death and may cause the formation of chronic collagenous scartissue.

Further, the inventor hypothesizes that the minimally traumatic methodof pushing aside and slipping past connective and fatty tissue with therounded tip of the insertion obturator allows the connective and fattytissue to move or pop back toward their original position as the trocaris removed from the insertion path and incision. As the connective andfatty tissue moves, slides, or pops back toward its original position,the connective and fatty tissues have the effect of locking or blockingthe delivered medication pellets in place.

Further still, the inventor hypothesizes that the locking or blockingaction of the connective and fatty tissue prevents or limits thelikelihood that the delivered medication pellets are inadvertentlyextruded from the subcutaneous tissue because of pressure, a fall, orother stress.

The inventor further hypothesizes that the minimally traumatic insertionand subcutaneous delivery of medication pellets allows the incision madeto insert the medication pellets to heal more quickly and decrease thelikelihood that a subcutaneously delivered or inserted medication pelletis inadvertently extruded from the subcutaneous tissue because ofpressure, a fall, or other stress.

Additionally, the inventor hypothesizes that the reduced inflammationcaused by the minimally traumatic trocar apparatus and methods reducethe degree and incidence of scarring at the incision and insertion site.This reduced degree and incidence of scarring enables repeat dosingusing the same insertion site.

The invasive, traumatic prior art methods of subcutaneous pelletinsertion cause blood to pool around the traumatized delivery site dueto local destruction of fatty tissue, creating pain, inflammation,higher incidences of infection, and a lubricated exit path along whichinserted pellets are more likely to be extruded. In contrast, thepresently disclosed systems and methods of minimally traumaticsubcutaneous pellet delivery allows pellets to sit in a layer of fattytissue with limited or minimal abnormal blood or lymph fluidssurrounding the delivered pellets. The inflammation and/or pain causedby the traumatic prior art method of destroying fatty tissues isundesirable both because of pain's effect on the patient's psyche andbecause the size of the local inflammatory cytokine response creates amilieu that poorly dissolves medication pellets, or fails to dissolvemedication pellets entirely. All of these issues are exacerbated formen, due in part to the larger doses required, with complicationsoccurring in men up to 30 times more often than in women. Variousstudies have shown extrusion rates for prior art methods of ˜1% up to12%. The inventor hypothesizes that this minimally traumatic deliveryallows the pellets to be recognized earlier by the body and absorbedmore quickly, predictably, and deliberately as a result, and as comparedto traumatic insertion. The minimally traumatic delivery triggers only aminor inflammatory cytokine response, sufficient to signal macrophagesto selectively surrounding and dissolve inserted pellets. By reducingthe concentration of cytokines at insertion sites as compared to priorart methods and apparatus, the minimally traumatic apparatus and methodsyield an unexpectedly improved pellet absorption rate. To date, nopellets inserted with the minimally traumatic apparatus and methodsdescribed herein have been extruded, resulting in a greatly improvedextrusion rate of 0%.

Additional benefits flow from the minimally traumatic design of thepresent invention. The absence of separate insertion and deliveryobturators, as well as the absence of cutting trauma when using theminimally traumatic trocar, reduce the time and complexity of pelletinsertion procedures significantly (˜6 minutes for a minimally traumaticinsertion compared to ˜20 for the Biote™ traumatic procedure). Thisreduced procedure time and complexity enable non-surgeons to perform theminimally traumatic method, lowering costs to both patient and surgeon.

It is to be understood that the detailed description of illustrativeembodiments are provided for illustrative purposes. Thus, the apparatus,system, kit and method presented above may evolve to benefit from theimproved performance and lower cost of the future hardware componentsthat meet the system and method requirements presented. The scope of theclaims is not limited to these specific embodiments or examples.Therefore, various process limitations, elements, details, and uses candiffer from those just described, or be expanded on or implemented usingtechnologies or materials not yet commercially viable, and yet still bewithin the inventive concepts of the present disclosure. The scope ofthe invention is determined by the following claims and their legalequivalents.

What is claimed is:
 1. A minimally traumatic trocar apparatus fordelivering one or more medication pellets to a subcutaneous insertionsite, the minimally traumatic trocar apparatus comprising: a bluntcannula with a tubular cannula body, wherein a surface of an anteriorend of the tubular cannula body includes a smooth edge, wherein theblunt cannula is formed with a medication slot disposed along thetubular cannula body, and wherein an inner diameter of the tubularcannula is at least 3 millimeters (mm); an obturator that includes ananterior rounded tip and an obturator body that is inserted within thetubular cannula body; and wherein the obturator extends through thetubular cannula body so that the anterior rounded tip of the obturatorextends past the anterior end of the tubular cannula body.
 2. Theminimally traumatic trocar apparatus of claim 1 wherein the cannulaincludes at least one cannula marking corresponding to a medicationlength of the one or more medication pellets and wherein the obturatorfurther includes at least one marking corresponding to the medicationlength.
 3. The minimally traumatic trocar apparatus of claim 1 whereinthe cannula has a length that ranges from 13 cm to 17 cm and theobturator has a length that ranges from 18 cm to 22 cm.
 4. The minimallytraumatic trocar apparatus of claim 1 configured to align at least twomedication pellets of the one or more medication pellets along anon-linear path.
 5. The minimally traumatic trocar apparatus of claim 1wherein the tubular cannula body includes an outer diameter of at least3.5 mm, and the obturator includes an outer diameter of at least 3 mm.6. The minimally traumatic trocar apparatus of claim 1 wherein aposterior end of the tubular cannula body includes a first couplingelement; and wherein the obturator includes a second coupling element.7. The minimally traumatic trocar apparatus of claim 6 wherein theobturator extends through the tubular cannula body so that the anteriorrounded tip of the obturator-and an anterior portion of the tubularobturator body extend past the anterior end of the tubular cannula bodywhen the first coupling element and the second coupling elementinterface to couple to one another so that the obturator and the cannularotate together as a single unit.
 8. The minimally traumatic trocarapparatus of claim 1 wherein the cannula includes a cannula handlefixedly coupled to the tubular cannula body; and wherein the obturatorincludes an obturator handle fixedly coupled to the tubular obturatorbody.
 9. A minimally traumatic trocar system for delivering one or moremedication pellets to a subcutaneous insertion site, the minimallytraumatic trocar system comprising: a blunt cannula with a tubularcannula body, wherein a surface of an anterior end of the tubularcannula body includes a smooth edge, wherein the blunt cannula is formedwith a medication slot disposed along the tubular cannula body, andwherein an inner diameter of the tubular cannula is at least 3millimeters (mm); an obturator that includes an anterior rounded tip andan obturator body; wherein the obturator extends through the tubularcannula body so that the anterior rounded tip of the obturator extendspast the anterior end of the tubular cannula body; the obturatorconfigured to be removed from the tubular cannula body; and the anteriorrounded tip of the obturator is configured to contact and push the oneor more medication pellets through the tubular cannula body to thesubcutaneous insertion site.
 10. The minimally traumatic trocar systemof claim 9 wherein the obturator includes an obturator handle coupled tothe tubular obturator body; wherein the cannula includes a cannulahandle fixedly coupled to the tubular cannula body.
 11. The minimallytraumatic trocar system of claim 9 wherein the tubular cannula bodyincludes at least one cannula marking corresponding to a medicationlength for the one or more medication pellets and wherein the tubularobturator body further includes at least one delivery markingcorresponding to the medication length.
 12. The minimally traumatictrocar system of claim 9 wherein the cannula has a length that rangesfrom 13 cm to 17 cm, the obturator has a length that ranges from 18 cmto 22 cm.
 13. The minimally traumatic trocar system of claim 9 whereinthe cannula has a length that ranges from 14 cm to 16 cm, the insertionobturator has a length that ranges from 19 cm to 21 cm.
 14. Theminimally traumatic trocar system of claim 9 configured to align atleast two medication pellets of the one or more medication pellets alonga non-linear path.
 15. The minimally traumatic trocar system of claim 9wherein the tubular cannula body includes an outer diameter of at least3.5 mm, and the obturator includes an outer diameter of at least 3 mm.16. The minimally traumatic trocar system of claim 9 wherein a posteriorend of the tubular cannula body includes a first coupling element; andwherein the obturator includes a second coupling element.
 17. Theminimally traumatic trocar apparatus of claim 16 wherein the obturatorextends through the tubular cannula body so that the anterior roundedtip of the obturator-and an anterior portion of the tubular obturatorbody extend past the anterior end of the tubular cannula body when thefirst coupling element and the second coupling element interface tocouple to one another so that the obturator and the cannula rotatetogether as a single unit.